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Manipal University Page 10
CHAPTER – II
REVIEW OF LITERATURE
Review of literature for the present study is broadly categorized into:
1. Chronic Diseases-Overview
2. Hypertension-Meaning, classification, causes, clinical manifestations,
treatment, complications and lack of drug responsiveness and Studies related
to prevalence of hypertension
3. Diabetes Mellitus-Meaning, ethiology and pathophysiology, charecteristics of
type1 and type2 diabetes mellitus, clinical manifestations, drug, complications,
Studies related to prevalence of diabetes mellitus
4. Studies related to prevalence of hypertension and diabetes
5. Medication compliance- Meaning, Studies related to drug compliance and
related factors, Studies done with Morisky scale
6. Studies related to client education
Chronic Diseases-Overview
According to WHO Chronic diseases are diseases of long duration and generally
slow progression. Chronic diseases, such as heart disease, stroke, cancer, chronic
respiratory diseases and diabetes, are by far the leading cause of mortality in the
world, representing 60% of all deaths. Out of the 35 million people who died from
chronic disease in 2005, half were under 70 and half were women.12
Non communicable Diseases (NCDs) are assuming alarming proportions in the
South-East Asia Region (SEAR) of WHO of which India is a part. They account
the 51% of all deaths and 44% of the disease burden in the Region. Therefore
NCDs should no longer be regarded as a problem confined to the developed
countries and affluent segments of society. In fact they are clearly emerging as
a major public health challenge in developing countries of SEAR.12
Manipal University Page 11
The changes in the economic, social and demographic determinants of health
and adoption of unhealthy lifestyles are contributing to observed
conversion in the disease pattern characterized by a progressive and
accelerated rise in morbidity and mortality due to NCDs in the Region. NCDs
are linked to a cluster of major risk factors such as tobacco use, unhealthy diets,
physical inactivity, obesity, high blood pressure, cholesterol and glucose
levels that are measurable and largely modifiable.
The majority of NCDs are preventable. Furthermore, the knowledge on cost-
effective interventions for NCDs and their risk factors at population, community
and individual level is available. However, the application of this knowledge is
hampered by inadequate recognition of the impact of NCDs on economic
development. Also the lack of financial support retards capacity development for
the prevention and control of NCDs in the Region. 12
The Commission on Chronic Illness in USA has defined "chronic diseases" as
"comprising all impairments or deviations from normal, which have one or more
of the following characteristics: are permanent, leave residual disability, are
caused by non-reversible pathological alteration, require special training of the
patient for rehabilitation, may be expected to require a long period of
supervision, observation or care".15
Non-communicable diseases (NCDs) include cardiovascular, renal, nervous and
mental diseases, musculooskeletal conditions such as arthritis and allied
diseases, chronic non-specific respiratory diseases (e.g., chronic bronchitis,
emphysema, asthma), permanent results of accidents, senility, blindness,
cancer, diabetes, obesity and various other metabolic and degenerative
diseases and chronic results of communicable diseases. Disorders of unknown
cause and progressive course are often labelled "degenerative".15
Chronic non-communicable diseases are assuming increasing importance
among the adult population in both developed and developing countries.
Cardiovascular diseases and cancer are at present the leading causes of death
Manipal University Page 12
in developed countries (e.g., North America) accounting for 70 to 75 percent of
total deaths. The prevalence of chronic disease is showing an upward trend in
most countries, and for several reasons this trend is likely to increase. For one
reason, life expectancy is increasing in most countries and a greater number of
people are living to older ages, and are at greater risk to chronic diseases of
various kinds. For another, the life-styles and behavioural patterns of people are
changing rapidly, these being favourable to the onset of chronic diseases.
Modern medical care is now enabling many with chronic diseases to survive.
The impact of chronic diseases on the lives of people is serious when measured
in terms of loss of life, disablement, family hardship and poverty, and economic
loss to the country. Developing countries are now warned to take appropriate
steps to avoid the "epidemics" of non-communicable diseases likely to come
with socio-economic and health developments.15
Based on current trends, it is expected that noncommunicablediseases (NCD)
will account for 73% of deaths and 60% of the global disease burden by 2020,
and will account for a major proportion of disease and deaths in India. These
deaths are mostly due to heart disease, strokes, diabetes mellitus, cancers and
lung diseases.16
As chronic diseases are becoming a dangerous epidemic, the present study
tried to explore about the most important of them ie hypertension and diabetes
mellitus.
HYPERTENSION
Meaning
Hypertension is a sustained elevation of Blood Pressure. In adults, hypertension
exists when systolic blood pressure (SBP) is equal to or greater than 140 mm Hg or
diastolic blood pressure (DBP) is equal to or greater than 90 mm Hg for extended
periods of time. The classification shown in table is of those not taking
antihypertensive drugs and not acutely ill. (Table1). The diagnosis of hypertension
Manipal University Page 13
requires that elevated readings be present on at least three occasions during several
weeks.17
Table-1 Classification of Blood Pressure for Adults Age 18 Years and Older17
BLOOD PRESSURE, MM HG
CATEGORY SYSTOLIC DIASTOLIC
Optimal <120 and <80
Normal <130 and <85
High normal 130-139 or 85-89
Hypertension (based on an average of 2 readings)
Stage 1 140-159 or 90-99
Stage 2 160-179 or 100-109
Stage 3 ≥180 or ≥110
Classification of Hypertension
The Table describes the BP classification used in the United States for people 18
years of age and older. The Joint National Commission classifies hypertension
according to stages (1to 3) with the addition of a "high normal" category. These
experts consider the person with BP in the high normal category to be at higher risk
for the development of definite hypertension and recommend more frequent
monitoring than the person with lower BP. The risk of progression from high normal
to definite hypertension is controversial. The etiology of hypertension can be
classified as either primary or secondary.17
Primary Hypertension: Primary (essential) hypertension is elevated BP without an
identified cause and accounts for 90% to 95% of all cases of hypertension. Although
the exact cause of primary hypertension is unknown, several contributing factors,
including increased SNS activity, overproduction of sodium-retaining hormones and
Manipal University Page 14
vasoconstrictors, increased sodium intake, greater than ideal body weight, diabetes
mellitus and excessive alcohol intake, have been identified. 17
Secondary Hypertension: Secondary hypertension is elevated BP with a specific
cause that often can be identified and corrected. This type of hypertension accounts
for 5% to 10% of hypertension in adults and more than 80% of hypertension in
children. If a person below age 20 or over age 50 suddenly develops hypertension,
especially if it is severe a secondary cause should be suspected. Clinical findings
that suggest secondary hypertension include unprovoked hypokalemia, abdominal
bruit, variable pressures with history of tachycardia, sweating and tremor, or a family
history of renal disease.
Causes of secondary hypertension include the following:
(1) coarctation or congenital narrowing of the aorta
(2) renal disease such as renal artery stenosis and parenchymal disease
(3) endocrine disorders such as pheochromocytoma. Cushing syndrome, and
hyperaldosteronism
(4) neurologic disorders such as brain tumors, quadriplegia. and head injury
(5) sleep apnea
(6) medications such as sympathetic stimulants (including cocaine), monoamine
oxidase inhibitors taken with tyramine-containing foods, estrogen replacement ther-
apy, oral contraceptive pills, and nonsteroidal antiinflammatory drugs (NSAIDs)
(7) pregnancy-induced hypertension. Treatment of secondary hypertension is
directed at eliminating the underlying cause. Secondary hypertension is a
contributing factor to hypertensive crisis.17
Clinical Manifestations
Hypertension is often called the "silent killer" because it is frequently asymptomatic
until it becomes severe and target organ disease has occurred. A patient with severe
hypertension may experience a variety of symptoms secondary to effects on blood
vessels in the various organs and tissues or to the increased workload of the heart.
These secondary symptoms include fatigue, reduced activity tolerance, dizziness,
palpitations, angina, and dyspnea. In the past, symptoms of hypertension were
thought to include headache, nosebleeds, and dizziness. However, unless BP is very
Manipal University Page 15
high or low these symptoms are not more frequent in people with hypertension than
in the general population.17
Complications
The most common complications of hypertension are target organ diseases (Table)
occurring in the heart (hypertensive heart disease), brain (cerebrovascular disease),
peripheral vasculature (peripheral vascular disease), kidney (nephrosclerosis), and
eyes (retinal damage).
Table-2 Manifestations of Target Organ Disease17
ORGAN MANIFESTATIONS
Cardiac
Clinical, electrocardiographic, or radiologic evidence of coronary artery diseases
Left ventricular hypertrophy or "strain" by electrocardiography or left ventricular hypertrophy by echocardiography
Left ventricular dysfunction or cardiac failure
Cerebrovascular Peripheral vascular
Transient ischemic attack or stroke Absence of one or more major pulses in the extremities (except for dorsalispedis) with or without intermittent claudication; aneurysm
Renal Serum creatinine ≥1.5 mg/dl (130 µmol L)
Proteinuria (1 ÷ or greater) Microalbuminuria
Retinopathy Hemorrhages or exudates with or without papilledema
Treatment
The goal of treatment is to prevent complications and death by achieving and
maintaining the arterial blood pressure at 140/90 mm of Hg or lower. The optimal
management plan would be one that is inexpensive and simple and causes the least
possible disruption in the patient‟s life. For patients with uncomplicated hypertension
and no specific indications for another medication, the recommended initial
Manipal University Page 16
medication includes diuretics, beta-blockers, or both. The table gives a list of various
pharmacologic agents that are recommended for the treatment of hypertension.17
Table-3 Drug therapy used in hypertension.17
DRUG MECHANISM OF
ACTION
SIDE EFFECTS
AND ADVERSE
EFFECTS
NURSING
CONSIDERATIONS
Diuretics
Thiazide and
Related Diuretics
bendroflumethiazide
benzthiazide
chlorthalidone
hydrochlorothiazide
metolazone
methyclothiazide
t\ichlormethiazide
Inhibit NaCI
reabsorption in
the distal
convoluted tubule;
increases
excretion of Na+
and CI Initial de-
crease in ECF;
sustained
decrease in SVR.
Lower BP
moderately in 2-4
wk.
Fluid and electrolyte
imbalances (volume
depletion, hy-
pokalemia,
hyponatremia,
hypochloremia,
hypomagnesemia,
hypercalcemia,
hyperuricemia,
metabolic alkalosis);
CNS effects (vertigo,
headache,
weakness); GI
effects (anorexia,
nausea, vomiting.
diarrhea,
constipation, pancre-
atitis); sexual
problems (impotence
and decreased
libido); blood
dyscrasias; and
dermatologic
(photosensitivity,
skin rash) effects.
Decreased glucose
Monitor for orthostatic
hypotension,
hypokalemia, and
alkalosis. Thiazides
may potentiate
cardiotoxicity of
digoxin by producing
hypokalemia. Dietary
sodium restriction re-
duces the risk of
hypokalemia. NSAIDs
can decrease diuretic
and antihypertensive
effect of thiazide
diuretics. Advise pa-
tient to supplement
with potassium-rich
foods. Current doses
are lower than previ-
ously recommended.
Manipal University Page 17
tolerance.
Loop Diuretics
bumetanide
ethacrynic acid
furosemide
torsemide
Inhibit NaCI
reabsorption in
the thick
ascending limb of
the loop of Henle.
Increase excretion
of Na+ and CI-.
More potent
diuretic effect than
thiazides, but
shorter duration of
action, less ef-
fective for
hypertension.
Fluid electrolyte
imbalance as with
thiazides, except no
hypercalcemia.
Ototoxicity (hearing
impairment,
deafness, vertigo)
that is usually
reversible. Metabolic
effects, including
hyperuricemia,
hyperglycemia,
increased LDL
cholesterol and
triglycerides with
decreased HDL
cholesterol.
Monitor for orthostatic
hypotension and
electrolyte abnormal-
ities. Loop diuretics
remain effective
despite renal
insufficiency. Diuretic
effect of drug
increases at higher
doses.
Potassium-Sparing
Diuretics
amiloride
triamterene
spironolactone
eplerenone
Reduce K+ and
Na+ exchange in
the distal and
collecting tubules.
Reduces
excretion of K+,
H+, Ca2+, and
Mg2+.
Inhibit the Na+
retaining and K +
excreting effects
of aldosterone in
the distal and
collecting tubules.
Hyperkalemia,
nausea, vomiting.
diarrhea, headache,
leg cramps, and
dizziness.
Same as amiloride
and triamterene;
may cause
gynecomastia,
impotence,
decreased libido,
and menstrual
irregularities.
Monitor for
orthostatichypotension
and hyperkalemia.
Potassium-sparing
diuretics are
contraindicated in
patients with renal
failure and uS6d with
caution in patients on
ACE inhibitors or
angiotensin II
blockers. Avoid
potassium
supplements.
Manipal University Page 18
Adrenergic
Inhibitors Central-
Acting Adrenergic
Agonists clonidine
Reduces
sympathetic
outflow from CNS.
Reduces periph-
eral sympathetic
tone, produces
vasodilation; de
creases SVR and
BP.
Dry mouth, sedation,
impotence, nausea,
dizziness, sleep
disturbance;
nightmares, restless-
ness,and
depression.
Symptomatic
bradycardia in
patients with
conduction disorder.
Sudden
discontinuation may
cause withdrawal
syndrome including
rebound tachycardia
hypertension,,
headache, tremors,
apprehension, and
sweating. Chewing
gum or hard candy
may relieve dry
mouth. Alcohol and
sedatives increase
sedation. May be
given transdermally
with fewer side effects
and better
compliance.
Guanabenz Same as
clonidine.
Same as clonidine. Same as clonidine,
but not available in
transdermal
formulation.
Guanfacine Same as
clonidine.
Same as clonidine. Same as clonidine,
but not available in
transdermal
formulation.
Methyldopa Same as
clonidine.
Sedation, fatigue,
orthostatic hy-
potension,
decreased libido,
impotence, dry
mouth, hemolytic
Instruct patient about
daytime sedation and
avoidance of
hazardous activities.
Administration of a
single daily dose at
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anemia,
hepatotoxicity,
sodium and water
retent.ion, psychic
depression.
bedtime minimizes
sedative effect.
Peripheral-Acting
Adrenergic
Antagonists
Guanethidine
Prevents
peripheral release
of norepinephrine.
resulting in
vasodilation;
lowers CO and
reduces SBP
more than DBP.
Marked orthostatic
hypotension,
diarrhea, cramps,
bradycardia,
retrograde or
delayed ejaculation,
sodium and water
retention.
May cause severe
postural hypotension;
not recommended for
use in patients with
cerebrovascular or
coronary insufficiency
or in older adults;
advise patient to rise
slowly and wear
support stockings.
Hypotensive effect is
delayed for 2-3 days
and lasts 7-10 days
after withdrawal. Once
daily dosing.
Guanadrel sulfate
reserpine
Same as
guanethidine.
Depletes central
and peripheral
stores of
norepinephrine;
results in
peripheral
vasodilation
(decreases SVR
and BP).
Similar to
guanethidine.
Sedation and
inability to con-
centrate; depression;
nasal stuffiness.
Must be given twice
daily. Contraindicated
in patients with history
of depression. Monitor
mood and mental
status regularly. Advise
patient to avoid
barbiturates, alcohol
and narcotics.
Manipal University Page 20
α1-Adrenergic
Blockers
doxazosin
prazosin
terazosin
Block α1-
adrenergic effects
producing
peripheral va-
sodilation
(decreases SVR
and BP).
Variable amount of
postural hypotension
depending on the
plasma volume. May
see profound
orthostatic hy-
potension with
syncope within 90
minutes after initial
dose. Retention of
salt and water.
Reduced resistance to
the outflow of urine in
benign prostatic
hyperplasia. Taking
drug at bedtime
reduces risks associ-
ated with orthostatic
hypotension.
Beneficial effects on
lipid profile.
Phentolamine Blocks α1-
adrenergic recep-
tors, resulting in
peripheral
vasodilation
(decreases SVR
and BP).
Acute, prolonged
hypotension, cardiac
arrhythmias,
tachycardia,
weakness, flushing.
Abdominal pain,
nausea, and ex-
acerbation of peptic
ulcer.
Used in short-term
management of
pheochromocytoma.
Also used locally to
prevent necrosis of
skin and subcutaneous
tissue after
extravasation of an a-
adrenergic drug. No
oral formulation.
βAdrenergic
Blockers
acebutolol
atenolol
betaxolol
bisoprolol
carteolol
carvedilol
Reduce BP by
antagonizing β
adrenergic
effects. Decrease
CO and reduce
sympathetic
vasoconstrictor
tone. Decrease
rennin secretion
by kidney.
Bronchospasm,
atrioventricular
conduction block,
impaired peripheral
circulation. Night-
mares, depression,
weakness, reduced
exercise capacity.
May induce or
exacerbate heart
β-Adrenergic blockers
vary in lipid solubility,
selectivity, and
presence of partial
sympathomimetic
effect, which explains
different therapeutic
and side effect profiles
of specific agents.
Monitor pulse
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metoprolol
nadolol
penbutolol
pindolol
propranolol
timolol
esmolol
Reduces BP by
antagonizing β
adrenergic
effects.
failure in susceptible
patients. Sudden
withdrawal of ,B-
adrenergic blockers
may cause rebound
hypertension and ex-
acerbate symptoms
of ischemic heart
disease.
regularly. Caution in
patients with diabetes
mellitus because drug
may mask signs of
hypoglycemia.
IV administration;
rapid onset and very
short duration of
action.
Combined α- and β
Adrenergic Blocker
labetalol
α1,β1 adrenergic
blocking
properties pro-
ducing peripheral
vasodilation and
decreased heart
rate. Reduces
CO, SVR, and BP.
Dizziness, fatigue,
nausea, vomiting,
dyspepsia,
paresthesia, nasal
stuffiness,
impotence, edema.
Hepatic toxicity.
Same as ,β-
adrenergic blockers.
IV form available for
hypertensive crisis in
hospitalized patients.
Patients must be kept
supine during IV
administration. Assess
patient tolerance of
upright position
(severe postural
hypotension) before
allowing upright
activities (e.g.,
commode).
Direct
Vasodilators
diazoxide
Reduces SVR and
BP by direct
arterial
vasodilation.
Reflex sympathetic
activation producing
increased HR, CO,
and salt and water
retention.
Hyperglycemia,
IV use only for
hypertensive crisis in
hospitalized patients.
Administer only into
peripheral vein.
Manipal University Page 22
especially in patients
with type 2 diabetes.
hydralazine Reduces SVR and
BP by direct
arterial
vasodilation.
Headache, nausea,
flushing, palpitation,
tachycardia,
dizziness, and
angina. Hemolytic
anemia, vasculitis,
and rapidly progres-
sive
glomerulonephritis.
IV use for
hypertensive crisis in
hospitalized patients.
Twicedaily oral
dosage. Not used as
monotherapy because
of side effects.
Contraindicated in pa-
tients with coronary
artery disease; used
with caution in pa-
tients over 40 years of
age.
minoxidil Reduces SVR and
BP by direct
arterial
vasoldilation.
Reflex tachycardia,
marked sodium and
fluid retention (may
require loop diuretics
for control), and
hirsuitism. May
cause ECG changes
(flattened and
inverted T waves)
not related to
ischemia.
Reserved for
treatment of severe
hypertension
associated with renal
failure and resistant to
other therapy. 'Once-
or twice daily dosage.
nitroglycerin Relaxes arterial
and venous
smooth muscle
reducing preload
and SVR. At low
dose, venous
Hypotension,
headache, vomiting,
flushing.
IV use for
hypertensive crisis in
hospitalized patients
with myocardial
ischemia.
Administered by
Manipal University Page 23
dilation pre-
dominates; at
higher dose
arterial dilation is
present
continuous IV infusion
with pump or control
device.
Use intraarterial moni-
toring of BP. Light-
resistant bags, bottles,
and administration
sets must be used;
stable for 24 hr.
Monitor thiocyanate
levels with prolonged
(2:24 to 48 hr) use.
sodium
nitroprusside
Direct arterial
vasodilation re-
duces SVR and
BP.
Acute hypotension,
nausea, vomiting.
muscle twitching.
Signs of thiocyanate
toxicity include
anorexia, nausea,
fatigue, and
disorientation.
Ganglionic Blockers
trimethaphan
Interrupts
adrenergic control
of arteries, results
in vasodilation,
and reduces SVR
and BP.
Visual disturbance,
dilated pupils, dry
mouth, urinary
hesitancy, subjective
chilliness.
IV use for initial
control of BP in
patient with dissecting
aortic aneurysm.
Administered by
continuous IV infusion
with pump or control
device.
Angiotensin
Inhibitors
Angiotensin-
Converting Enzyme
Inhibitors
benazepril
captopril
enalapril
fosinopril lisinopril moexipril
perindopril
Inhibit
angiotensin-
converting
enzyme; reduce
conversion of
angiotensin I to
angio tensin II (A-
II); prevent A-II-
mediated vasocon
striction. Inhibit
Hypotension, loss of
taste, cough,
hyperkalemia, acute
renal failure, skin
rash, angioneurotic
edema. Same as
oral forms.
Aspirin and NSAIDs
may reduce drug
effectiveness. Addition
of diuretic enhances
drug effect Should not
be used with
potassium-sparing
diuretics. Can cause
fetal morbidity or
mortality. Captopril
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quinapril
ramipril
trandolapril
enalaprilat
angiotensin
converting
enzyme when oral
agents not
appropriate..
may be given orally
for hypertensive crisis.
Given IV over 5
minutes; may be given
every 6 hr.
Angiotensin II
Receptor Blockers
candesilrtan
eprosartan
irbesartan
losartan
olmesartan
telmisartan
tasosartan
valsartan
Prevent action of
angiotensin II and
produce
vasodilation and
increased salt and
water excretion.
Hyperkalemia,
decreased renal
function.
Full effect on BP may
not be seen for 3-6
wk.
Calcium Channel
Blockers
amlodipine
diltiazem
felodipine
isradipine
mibefradil
nicardipine
nifedipine
nisoldipine
verapamil
Block movement
of extracellular
calcium into cells,
causing
vasodilation and
decreased SVR.
Nausea, headache,
dizziness, peripheral
edema. Reflex
tachycardia (with
dihydropyridines).
Reflex decrease HR
(with diltiazem);
constipation (with
verapamil).
Use with caution in
patients with heart
failure.
Contraindicated in
patients with second-
or third-degree heart
block. IV nicardipine
available for hy-
pertensive crisis in
hospitalized patients.
Sustained-release for-
mulations for some
drugs. Avoid
grapefruit when on
nifedipine.
Manipal University Page 25
Side effects and adverse effects of antihypertensive drugs may be so undesirable
that the patient may not comply with therapy. The table gives reasons for lack of
responsiveness to therapy which includes non compliance to drug.
Table-4 Causes for lack of Responsiveness to therapy
Nonadherence to therapy
Cost of medication
Instructions not clear or not given to
the patient in writing
Inadequate or no patient teaching
Lack of involvement of the patient in
the treatment plan
Side effects of medication
Dementia
Inconvenient dosing
Drug – related causes
Dosages too low
Inappropriate combinations
Rapid inactivation
Drug interactions
Nonsteroidal anti-inflammatory drugs
Oral contraceptives
Sympathomimetics
Antidepressants
Adrenal Corticosteroids
Nasal decongestants
Licrorice containing substance (eg.,
chewing tobacco)
Cocaine
Cyclosporine
Erythropoietin
Associated conditions
Increasing obesity
Alcohol intake more than 1 oz/day
Secondary Hypertension
Renal insufficiency
Renovascular hypertension
Pheochromocytoma
Primary aldosteronism
Volume overload
Inadequate diuretic therapy
Excess sodium intake
Fluid retention from reduction of
blood pressure
Progressive renal damage
Pseudohypertension
Manipal University Page 26
Studies related to prevalence of hypertension
In a study conducted in Northern India, it was found that there was a rising trend in
the prevalence of hypertension over the last 3 decades. The people of seven villages
in the age group of 17-70 years were interviewed. The prevalence of hypertension
was 4.5% and was higher among females than males and only 26.3% of all
hypertensive were aware of their disease and only 3.5% had regular treatment.4
In an ICMR study
in 1994 involving 5537 individuals (3050 urban residents and 2487
rural residents) demonstrated 25% and 29% prevalence of hypertension (Criteria:
>=140/90 mm of Hg) among males and females respectively in urban Delhi and 13%
and 10% in rural Haryana From south India, Kutty VR
carried out hypertension
prevalence study (criteria: >=160/95 mm of Hg) in rural Kerala during 1991 in the 20
plus age group and the prevalence was found to be 18%. Later studies in Kerala
(Criteria: JNC VI) reported 37% prevalence of hypertension among 30-64 age group
in 1998 and 55% among 40-60 age group
during 2000. A higher prevalence of 69%
and 55% was recorded among elderly populations aged sixty and above in the urban
and rural areas respectively during 2000. The Sentinel Surveillance Project,
documented 28% overall prevalence of hypertension (criteria: =JNC VI) from 10
regions of the country in the age group 20-69. 5
In a multi centric study
involving six urban cities in India (Chennai, Bangalore,
Hyderabad, Mumbai, Culcutta and New Delhi) in the country among the age group of
20 and above showed a prevalence of 14% among men and women (sample size:
5288 men; 5928 women). The Sentinel Surveillance Project, documented 10%
overall prevalence of diabetes from 10 regions of the country using the criteria (FPG
> 126 mg/dl or on treatment) in the age group 20-69. 5
A survey conducted at Assam has mentioned in their annual report that 3180 people
from 5 districts who were 30+ years were included in the study where an interview
was done followed by assessments for anthropometric measurements, blood
pressure and ECG monitor for coronary heart disease. The prevalence in the study
population was 33.3% and 22% were aware of the blood pressure.18
Manipal University Page 27
A study to identify the Prevalence of hypertension in coastal Karnataka was done to
estimate the prevalence and socio demographic correlates among adults above 30
years. It was a community based cross-sectional study carried out on a population of
1,239 respondents, using a two-stage stratified, probability proportional to size
sampling technique. Study variables included, socio-demographic characteristics,
physical activity, blood pressure and blood glucose measurements, anthropometric
measurements, family history of hypertension and diabetes. The study included
1,419 subjects with a response rate of 87.3%. Among the respondents 434 (35%)
were males and 805 (65%) were females. The prevalence of hypertension was found
to be 43.3%. Based on JNC VII classification, pre-hypertension was noted among
41.4% of the subjects, with 43.7% individuals being in the 30-39 year age group.
Advancing age, male gender, current diabetic status, central obesity, being
overweight and obese as defined by BMI were identified by the multivariate logistic
regression model to be associated with the presence of hypertension. 19
Diabetes Mellitus
Meaning
It is a multisystem disease related to abnormal insulin production, impaired insulin
utilization, or both. Diabetes mellitus is a serious health problem throughout the
world. 17
Etiology and Pathophysiology
Current theories link the causes of diabetes, singly or in combination, to genetic,
autoimmune, viral and environmental factors (e.g obesity, stress). Regardless of its
cause, diabetes is primarily a disorder of glucose metabolism related to absent or
insufficient insulin supplies and / or poor utilization of the insulin that is available. 17
Although the American Diabetes Association (ADA) recognize 11 different
classifications of the disease, most of these types are rarely encountered in routine
nursing practice. The two most common types of diabetes are classified as type 1 or
type 2 diabetes mellitus. Gestational diabetes and secondary diabetes are other
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classifications of diabetes commonly seen in clinical practice. The table shows the
difference in charecteristics of type-1 and 2 diabetes mellitus.17
Table-5 Chacteristics of type 1 and type 2 Diabetets Mellitus 17
Factor Type 1 Diabetes
Mullitus
Type 2 Diabetes Mullitus
Age at onset More common in young
person but can occur at
any age
Usually age 35 yr or older
but can occur at any age
Incidence is increasing in
children
Type of onset Sign and symptoms
abrupt but disease
process may be present
for several years
Insidious
Prevalence Accounts for 5% - 10% of
all types of diabetes
Accounts for 90% of all
types of diabetets
Environmental factors Virus, toxins Obesity, lack of exercise
Islet cell antibodies Often present at onset Absent
Endogenous insulin Minimal or absent Possibly excessive;
adequate but delayed
secretion or reduced
utilization
Nutritional status Thin catabolic state Obese or possibly normal
Symptoms Thirst polyuria
polyphagia, fatigue
Frequently none or mild
Ketosis Prone at onset or during
insulin deficiency
Resistant except during
infection or stress
Nutritional therapy Essential Essential possibly sufficient
for glycemic control
Insulin Required for all Required for some
Oral hypoglycemic agents Not beneficial Usually beneficial
Vascular and neurologic
complications
Frequent Frequent
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Clinical Manifestations
Type 1 Diabetes Mellitus: Because the onset of type 1 diabetes is rapid, the
initialmanifestations are usually acute. The classic symptoms are polyuria (frequent
urination) polydipsia (excessive thirst) and polyphagia (excessive hunger). The
osmotic effect of glucose produces the manifestations of polydipsia and polyuria.
Polyphagia is a consequence of cellular malnourishment when insulin deficiency
prevents utilization of glucose for energy. Weight loss may occur as the body cannot
get glucose and turns to other energy souces, such as fat and protein. Weakness
and fatigue may also be experienced as body cells lack needed energy from
glucose. Ketoacidosis, a complication associated with untreated type 1 diabetes, is
associated with additional clinical manifestations.17
Type 2 Diabetes Mellitus: The clinical manifestations of type 2 diabetes are often
nonspecific, although it is possible that an individual with type 2 diabetes will
experience some of the classic symptoms associated with type 1. Some of the more
common manifestations associated with type 2 diabetes include fatigue recurrent
infections prolonged wound healing and visual changes. Unfortunately the clinical
manifestations appear so gradually that before the person knows it he or she may
have complications. 17
Drug therapy
Insulin
Exogenous (injected) insulin is needed when a patient has inadequate insulin to
meet specific metabolic needs and the combination of nutritional therapy, exercise,
and Oral agents cannot maintain a satisfactory blood glucose level. The problems
with insulin therapy are hypoglycemia, allergic reactions, lipodystrophy and somogyi
effects.
Somogyi effect or chronic somogyi rebound is a rebounding high blood sugar that is
a response to low blood sugar. In context of managing the blood glucose level
manually with insulin injections this effect is counter-intuitive to insulin users who
experience high blood sugar in the morning as a result of an over abundance of
insulin at night. This controversial phenomenon was named after Dr.Michael
Somogyi. 20
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Oral agents(OAs)
They are not insulin, but they work to improve the mechanisms by which insulin and
glucose are produced and used by the body. For any of the OAs to be effective, the
patient must have circulating endogenous insulin. There are currently no OAs to treat
type1 diabetes. It may be used in combination with agents from other classes or with
insulin to achieve blood glucose targets. Guidelines for assessing patients receiving
OAs are given in table below.17
Table-6 Oral agents for diabetes mellitus17
Type Mechanism of action Side effects
First generation
sulfonylureas
Tolbutamide
Acetohexamine
Tolazamide
Cholopropamide
Stimulate release of insulin from
pancreatic islets; decrease
glycogenolysis and gluconegoenesis
enhance cellular sentivity to insulin
Weight gain,
hypoglycemia
Second Genreation
sulfonylureas
Glipizide
Glyburide
Glimepiride
Stimulate release of insulin from
pancreatic islets decrease glycogenolysis
and gluconeogensis; enhance cellular
sensitivity to insulin
Weight gain
hypoglycemia
Meglitindes
Repaglinide Nateglinide
Stimulate a rapid and short lived release
of insulin from the pancreas
Weight gain
hypoglycemia
Biguanide
Metformin
Rate of hepatic glucose production
augments glucose uptake by tissues
especially muscles
Diarrehea lactic
acidosis
α-Glucosidase inhibitors
acarbose
Miglito
Delay absorption of glucose from GI tract
Gas, abdominal pain,
diarrhea
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Thiazolidinediones
Pioglitazone
Rosiglitazone
Glucose up take in muscle endogenous
glucose production
Weight gain edema
Combination therapy
Glucovance
Avandmet
Metaglip
Combination of metformin and glyburide
Combination of rosiglitazone and
metformin
Combination of metformin and glipizide
Nausea, diarrhea
abdominal pain lactic
acidosis weight gain
hypoglycemia
Table-6a Injectable non-insulin drugs
S.No Name Action Side effects
1. Exenatide (Byetta)21 It is an incretin mimetic which
stimulates insulin production and
helps the person to feel full by
delaying emptying of stomach.
Hypoglycemia
2. Pramlintide(SymlinR)21 It is a synthetic version of amylin
which helps the person feel full by
delaying the emptying of stomach.
Nausea, vomitting
3. Liraglutide-r DNA
origin(Victoza R)22
Is 97% similar to the hormone
GLP_1 which signals beta cells to
release insulin hence it helps beta
cells to release insulin.
Thyroid cancer,
pancreatitis
Complications
Chronic complications of diabetes are primarily those of end organ disease that
result from damage to the large and small blood vessels from chronic hyperglycemia.
Based on studies conducted by the American Diabetes Association has given
recommendations for ongoing evaluation which is listed below.17
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Table-7 Complications of diabetes mellitus and the detection methods17
Complication Type of Examination Frequency
Retinopathy Funduscopic- dilated eye
examination
Annually
Nephropathy Urinalysis for microalbuminuria Annually
Neuropathy(foot and
lower extremities)
Visual examination of foot
Comprehensive foot examination:
-visual examination
-sensory examination with
monofilament and tuning fork
-palpation(pulses, temperature,
callus formation)
Daily by patient,
every visit by health
care provider
Annually
Cardiovascular disease Blood pressure
Lipid panel
Exercise stress testing (may include
stress ECG, stress echocardiogram,
perfusion imaging)
Every visit
Annually
As needed based
on risk factors
Studies related to prevalence of diabetes
A study has reported that WHO estimates 135 million diabetic cases in 1995 and this
number would increase to 300 million by the year 2025. It also states that India will
lead the world with the largest number of diabetics in any given country.6
In a study on prevalence of diabetes in a rural area of central India observed
34(3.67%) were diabetic out of a total 122(13.20%) who had abnormal glucose
tolerance in a rural area of Nagpur district23. In this study nine hundred and twenty
four subjects aged greater than or equal to 30 were selected by systematic random
sampling of houses, and all subjects were interviewed using a standardized
proforma and screened by 75g oral glucose tolerance test based on WHO criteria.
The prevalence of diabetes found is high compared to that in the WHO report (2.4%)
for rural India. The study also found that upper socioeconomic class, family history of
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diabetes, reduced physical activity, and increased BMI, were important predictors of
diabetes.
A study on “Prevalence of diagnosed diabetes in an urban area of Puducherry, India:
Time for preventive action”24 aimed to estimate the number of persons diagnosed
with diabetes in Puducherry. Diabetes was diagnosed retrospectively from all family
folders of 2667 families(population 11835) for the period 2003-06. The data was
verified by home visits. It was found 643 individuals had been diagnosed with
diabetes and the prevalence was estimated to be 5.6%(5.31% in males and 6.1% in
females), age-specific findings were 8.2% in the age group of ≥20 years and above
20% after the age of 50 years. The study also concluded that diabetes is more
prevalent after the age of 40 years.
The global prevalence of diabetes –estimates for the year 2000 and projections for
203025 predicted a prevalence rate of 4.4% in 2030 ie upto 366million. It is due to an
increase in urban population and of people > 65 years.
A Study of prevalence of diabetes mellitus and impaired fasting glucose in a rural
population was conducted with the main aim to estimate the prevalence of diabetes
mellitus and Impaired Fasting Glucose(IFG) in Suttur Village, Karnataka State26. A
cross sectional survey was carried out in this village to estimate the prevalence of
diabetes and IFG. Blood samples were collected with a minimum of eight hours
fasting. Estimation of blood sugar was done by GOD/POD method. The ADA 1997
criteria was adopted for diagnosis of impaired fasting glucose (IFG) and Diabetes
mellitus (DM) The prevalence rate (percent) of diabetes mellitus for persons above
the age of 25 years was 3.77%. The prevalence in males was 4.58% and in females
it was 2.66%. Impaired fasting glucose was 2.82% in male and 2.78 % in female.
The maximum prevalence was observed in the age group of 56 to 65 in both males
and females. There was no significant difference in the prevalence of IFG among the
three different communities; the study has highlighted the association of age, sex
and community, with prevalence of diabetes.
A study done in Karnal district, Haryana27 tried to identify the prevalence of type I
diabetes in north India as previous data were from Karnataka registry which showed
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an incidence of 3.7/1lakh in boys and 4/1lakh in girls above 13 years and population
based study in urban Chennai 1996 an incidence of 10.5/1lakh and overall in India
estimates of 1.6 to 10.5/1lakh had been reported. The study used hospital based
registry to identify prevalence. The results were out of 222017 population of Karnal
diabetes prevalence was 10.2/1lakh population, in urban 26.6/1lakh, rural
4.27/1lakh.The prevalence rates of type I diabetes was 31.9/1lakh,men-
11.56/1lakh,women-8.6/1lakh 5-16years-22.22/1lakh and 0-5years-3.82/1lakh.This
study thus highlights the prevalence of type I diabetes in the various gradients of
population at Karnal.
Studies related to prevalence of hypertension and diabetes
The Karnataka state health policy 200428, states that Karnataka carries a double
burden of communicable and non-communicable diseases. The latter include, in
particular cardiovascular diseases, including hypertension, cancers and diabetes.
The prevalence/incidence of various NCDs for 1998 has also been estimated, for
India, based on various published studies from different regions. These estimates
may be relatively conservative, as suggested by the comparison with the diabetes
prevalence estimates of the World Health Organization. Even then, it is estimated
that about one-fifth of the population would have at least one of these selected NCDs
Report of National Cardiovascular Disease Database Supported by Ministry of
Health & Family Welfare, Government of India and World Health Organization has
given the prevalence studies for diabetes and hypertension.The MEDLINE, EMBASE
and INDMED databases from 1940-2005, were searched to obtain prevalence
studies on hypertension in Indian population. The search terms used were
“prevalence”, “hypertension”, “high blood pressure”, “coronary risk factors”, and
“India”. Using the above literature search techniques, fifty-two epidemiological
studies published between 1940 and 2005 were identified. All the studies identified
were cross sectional in nature. The study location (urban vs rural), age group
studied, sample size, criteria for diagnosis of hypertension, prevalence of
hypertension in the total group, men and women were classified separately. There
were marked heterogeneity among studies mostly due to the varying time periods of
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data collection and differing definitions of hypertension. However, prevalence of
hypertension based on JNC V criteria was available from 22 studies across India.
The earliest study was conducted by Dubey VD (1954), documented 4% prevalence
of hypertension (criteria:>160/95) amongst industrial workers of Kanpur. Later
studies in Kerala (Criteria: JNC VI) report 37% prevalence of hypertension among
30-64 age group
in 1998 and 55% among 40-60 age group
during 2000. A higher
prevalence of 69% and 55% was recorded among elderly populations aged sixty and
above in the urban and rural areas respectively during 2000. Few studies on
prevalence on hypertension are available from eastern Indian population. In 2002,
Hazarika et al
reported 61% prevalence (criteria: =JNC VI) among man and women
aged thirty and above in Assam. The Sentinel Surveillance Project, documented
28% overall prevalence of hypertension (criteria: =JNC VI) from 10 regions of the
country in the age group 20-69. A study conducted in the urban areas of Chennai
during 2000
(age group>=40) reported a higher prevalence of hypertension (54%)
among low income group (monthly income < Rs 30000/annum and 40% prevalence
among high-income group (monthly income > Rs 60000/annum). Misra et al
reported
12% prevalence of hypertension in the slums of Delhi. 5
Prevalence studies on Diabetes were identified as using the same methodology
described previously. The search terms used were “prevalence”, “diabetes”
“hypertension”, “coronary risk factors”, “glucose abnormalities”, “dysglycaemia”,
“coronary”, “insulin and metabolic syndrome” and “India”. Using the above literature
search techniques, twenty-seven epidemiological studies published between 1950
and 2005 were found. All the studies identified were cross sectional in nature. The
study location (urban Vs rural), age group studied, sample size, criteria for diagnosis
of diabetes, prevalence of diabetes in the total group, men and women tabulated
separately. There were marked heterogeneity among studies mostly due to the
varying time periods of data collection and differing definitions of diabetes. During
1972-75, ICMR
carried out a large multicentric study in India, which documented
2.6% and 1.5% prevalence of diabetes (criteria: FBS>5.6mmol/l or Post 1-h glucose
value>=7.8mmol/l or Post 2-h glucose value>=6.7mmol/l) among men and women in
the urban areas while in rural areas had a lower prevalence: 1.8% and 1.3%
respectively. In 1994, Wander GS reported 5% prevalence of diabetes (criteria:
random venous blood glucose >180mg/dl or history) among a rural population
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Ludhiana, Punjab. Further, Gupta R from Jaipur, through three epidemiological
studies carried out during 1994, 2001
and 2003
demonstrated rising trend rates of
diabetes (criteria: FBS>126mg/dl or history) 1%, 13%, and 18% respectively among
males and 1%, 11% and 14% respectively among females. In 2000, a multi centric
study
involving six urban cities in India (Chennai, Bangalore, Hyderabad, Mumbai,
Culcutta and New Delhi) in the country among the age group of 20 and above
showed a prevalence of 14% among men and women (sample size: 5288 men; 5928
women). The Sentinel Surveillance Project, documented 10% overall prevalence of
diabetes from 10 regions of the country using the criteria (FPG > 126 mg/dl or on
treatment) in the age group20-69.4. 5
A study on the Prevalence of diabetes, obesity, hypertension and hyperlipidemia in
the central area of Argentina29 had studied representative samples of the population,
based on a multistage probabilistic sampling design; samples were taken from each
of the four cities. The sample size was calculated to obtain a precision of 4% for the
prevalence assessment. The subjects included were aged 20 years and over.
Standardization of the prevalence rates used, the entire study sample as the
reference population. Age-standardised prevalence rates for the cities ranged
between 22.4% and 30.8% for obesity, 27.9% and 43.6% for hypertension, 24.2%
and 36.4% for hyperlipidemia, and 6.5% and 7.7% for diabetes mellitus. All these
prevalences increased with age. 58.1% of the obese subjects and 51.2% of the
diabetic subjects had hypertension, while 43.2% of the obese subjects and 52.8% of
the diabetic subjects had hyperlipidemia.
The report of the working group on communicable and non communicable diseases
for the 11th five year plan September 2006 by Dr.RK Srivastava30 has given the
following comments India is experiencing a rapid health transition, with a large and
rising burdens of chronic diseases, which are estimated to account for 53% of all
deaths and 44% of Disability Adjusted Living Years lost in 2005. Non-communicable
Diseases, especially diabetes mellitus, cardiovascular diseases, cancer, stroke and
chronic lung diseases have emerged as major public health problems due to an
ageing population and environmentally-driven changes in behavior. The premature
morbidity and mortality in the most productive phase of life is posing a serious
challenge to Indian society and its economy. India has the largest number of people
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with diabetes in the world, with an estimated 19.3 million in 1995 and projected 57.2
million in2025. The prevalence of type-2 diabetes in urban Indian adults has been
reported to have increased from less than 3% in 1970 to about 12% in 2000. Nearly
2.7 crore CHD cases(urban-1.2 crores and rural-1.5 crores) are estimated to have
occurred in 2000 which will double to nearly 6.1 crores cases in 2015. A total of 6.4
crore cases of CVD are likely in the year 2015 of which 96% would be CHD cases
and death from this group of diseases are likely to amount to be a
staggering34lakhs.
The studies on prevalence of hypertension and diabetes gave an insight into the
magnitude of the problem. The prevalence being very high, it needs an intervention
so as to bring down the complications and the morbidity rates.
Medication Compliance
Meaning
Adherence to (or compliance with) a medication regimen is generally defined as the
extent to which patients take medications as prescribed by their health care
providers. The word “adherence” is preferred by many health care providers,
because “compliance” suggests that the patient is passively following the doctor‟s
orders and that the treatment plan is not based on a therapeutic alliance or contract
established between the patient and the physician. Both terms are imperfect and
uninformative descriptions of medication-taking behavior. Adherence rates are
typically higher among patients with acute conditions, as compared with those with
chronic conditions; persistence among patients with chronic conditions is
disappointingly low, dropping most dramatically after the first six months of therapy.2
According to International Society for pharmocoeconomics and outcomes research;
Medication compliance (synonym: adherence) refers to the act of conforming to the
recommendations made by the provider with respect to timing, dosage, and
frequency of medication taking. Therefore medication compliance may be defined as
“the extent to which a patient acts in accordance with the prescribed interval and
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dose of a dosing regimen.” Compliance is measured over a period of time and
reported as a percentage.31
Compliance (or adherence) is a medical term that means the degree to which a
patient correctly follows medical advice. The most effective way for a doctor to
improve patient‟s compliance is through a positive physician-patient relationship.2
Other factors that increase compliance include:
Patient feeling ill
Limitations of patients activities due to disease state
Written instructions for taking medication
Acute illness
Simple treatment schedule
Short time spent in waiting room
Physician recommending one change at a time
Benefits of care outweigh costs
Peer support
Patients may not accurately report back to health care workers because of fear of
possible embarrassment, being chastised, or seeming to be ungrateful for a doctor's
care. Causes for poor compliance include:2
Forgetfulness
Poor rapport with physician
Few symptoms
Chronic illness
Prescription not collected or not dispensed
Purpose of treatment not clear
Perceived lack of effect
Real or perceived side-effects
Instructions for administration not clear
Physical difficulty in complying (e.g. opening medicine containers, handling
small tablets, swallowing difficulties, travel to place of treatment)
Unattractive formulation, such as unpleasant taste
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Complicated regimen
Cost of drugs
Studies on drug compliance and related factors
In an article on Compliance in Hypertension states that non compliance is a
universal characteristic and can affect all patients. The major problem is that it is not
recognized in clinical practice. Good communication with the patient is essential to
prevent non compliance. Long acting drugs can also be recommended.8
In the study the multilevel compliance challenge9; it is stated that compliance is a
complex behavioural pattern strongly influenced by the environment in which the
patient lives, healthcare providers practice and health care systems delivery of care.
The health care providers including pharmacists, nurses, psychologists etc who are
involved in primary and secondary prevention play a role in enhancing compliance
by interpreting recommendations, educating and motivating patients, monitoring
responses to recommended behaviours and providing feedback. Maximum use of
these services should be made by patients to overcome non compliance to drugs.
Multilevelapproach of education and behaviour change is important like consumer
health education, provider education, etc.
In the study on Challenges in diabetes management with particular reference to
India32 states that diabetes was estimated to be responsible for 109 thousand
deaths, 1157 thousand years of life lost and for 2263 thousand disability adjusted life
years in India during 2004. The study also identifies that health systems have not
matured to manage diabetes effectively and indicate that 50-60% of diabetic patients
donot achieve glycemic target of HbA1C below 7%. It cites that the cost of treatment,
need for lifelong medication, coupled with limited availability of anti-diabetic
medications in the public sector and cost in the private sector are important issues
for treatment compliance.
In a study on Development and validation of a survey to assess barriers to drug use
in patients with chronic heart failure33 used the barriers to medication survey and
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administered it to 128 consecutive patients attending an outpatient heart failure
clinic. Patients were also required to complete the Minnesota living with heart failure
questionnaire and a self reported drug scale. Patients with good adherence reported
few barriers (Pearson‟s correlation coefficient r=−0.14, p=0.14), patients who
reported few barriers also reported few MLHF scores(r=0.42, p<0.001) with a
strongest support in the social support domain(r=0.53, p<0.001).All respondents
reported having a good relationship with health care professionals and the most
common barriers to drug use were poor support networks and previous adverse
reactions.
In a study on Assessment of factors influencing Blood pressure control in a managed
care population used a retrospective analysis34 and randomly selected 502 patient
records from three primary care clinics in southeast Michigan. These patients took
fewer blood pressure drugs throughout the year (p=0.023) and had lower anti
hypertensive costs than those who had not achieved HEDIS blood pressure goals.
46% of the diabetic patients were at their blood pressure goal of below 130/85 mm of
Hg and 71.6% of them were managed with angiotensin-converting enzyme inhibitors
or angiotensin receptor blockers. Among the participants with antihypertensive
therapy 37.6% received β blockers, 50.5 % ACE inhibitors, 5.9% angiotensin
receptor blockers, 22.7% calcium channel blockers, 38.9 % diuretics, 9.5% α
blockers, <1% vasodilators 7.6% other drugs and no one was using ganglionic
blockers.
A study was done on Relationship between drug therapy noncompliance and patient
characteristics, health related quality of life, and health care costs35in which
computerized prescription records from 1054 patients at high risk for drug related
problems were studied, the compliance ratio for a 12 month period was calculated
and correlated with health care use, demographic variables, drug-related variables
and scores for health related quality of life. The difference between compliant and
noncompliant clients were found significant in several characteristics like age
(p=0.05), higher number of chronic conditions(p<0.001) and taking more
drugs(p<0.001) but logistic regression revealed that only the number of chronic
conditions was a significant factor for non compliance (0.665, CI 0.593-0.745). The
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study also concludes that compliance was not a predictor of concurrent or future
hospitalizations or mortality, nor a significant predictor for health care costs.
A study was done on drug compliance among hypertensive patients in Tabuk, Saudi
Arabia36, it was a prospective study where compliance was checked by pill counting
method and the reasons were analysed. The compliance rate was 53% it was
associated positively with male sex and negatively with older age, symptoms of
illness and drug side effects. The degree of blood pressure control was worse
among noncompliant subjects. Reasons for non compliance identified included
asymptomatic nature of hypertension, shortage of drugs, side effects, forgetfulness
and lack of health education.
A survey was conducted in US by Harris Interactive online survey37 in which 2507
US adults participated between March 16 and 18 2005. It was done for The Wall
Street Journal Online‟s health Industry Edition. The results reveal that out of the 63%
(1648) adults who had prescription drugs prescribed to them to be taken regularly in
the last year nearly two thirds 64% report they had forgotten to take their medication,
with 11% stating that this had happened often or very often (2005). The other
reasons cited by the people are:
I had no symptoms or the symptoms went away 36%
I wanted to save money 35%
I didn‟t believe the drugs were effective 33%
I didn‟t think I needed to take them 31%
I had painful or frightening side effects 28%
The drugs prevented me from doing other things I wanted
to do
25%
A study on Compliance and knowledge of hypertensive patients attending PHC
centres in AL-Khobar, Saudi Arabia38 was a cross-sectional study of all hypertensive
patients (190) attending four primary health centres.The mean age was 49.9±11.7
years, the overall compliance rate was 34.2% which was lower in those aged <55
years than older patients (26.2% versus 48.5%, p< 0.001) and among educated than
illiterate (30.4%and 38.1% respectively, p<0.001). The knowledge level regarding the
disease was very minimal as 41.6% of the patients thought that hypertension could
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have a permanent cure and 43.7% that medication could be stopped once control
was achieved. As to the etiology 66.3% thought as emotional stress and 1.6% as
heredity. Hence an education on hypertension is essential among these patients.
A study was done to identify the prevalence, awareness and compliance to treatment
among the Parsi community in Bombay39. It was identified that among 2879 subjects
>or = 20 years of age were randomly selected of which 2415 participated in the
study. The overall prevalence of hypertension in the community was 36.4% of which
48.5% were unaware of their hypertensive status. Among those aware 36.4% were
non compliant with their hypertensive drugs and only 13.6% had optimally controlled
hypertension.
In a study on treatment seeking behavior and compliance of diabetic patients in a
rural area of south India it is reported that out of 112 patients interviewed 72% had
some symptoms at the time of diagnosis and the majority of them were diagnosed in
government health centers; non compliance was seen in 57% of the 112 patients
interviewed and the reasons identified were lack of patient friendly, flexible health
care system. 40
In a study conducted by glycemic control and medication compliance in diabetic
patients in a pharmacist managed clinic in Hong Kong41; non compliant patients were
assessed by nurses and sent to the pharmacist. The clients had to visit the clinic
three times. During the first visit (week 0), the pharmacist used either direct pill
counts or questioning to assess the baseline compliance rate. The second visit
usually occurred at week 2 and the final visit at weeks 10-12. The reasons for the
patients' noncompliance and any problems encountered in their therapies were
documented. A 15- to 30-minute diabetes education session was arranged for each
patient. During the session, the pharmacist obtained a medication history; evaluated
drug compliance; provided drug information; educated the patient about diet,
exercise, smoking cessation, hypoglycemia, and sick-day management; and
monitored adverse drug reactions. Information on monitoring blood glucose and
hemoglobin A1c (HbA1c) levels and preventing complications was also presented.
The pharmacist gave the patient's physician therapeutic recommendations for
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achieving the goal of an HbA1c concentration of less than 7%. At the end of the third
visit, patients completed a satisfaction questionnaire. Out of 95 patients, 91 gave
complete data. The compliance rate at the beginning and at the end of third visit was
41.3±25.6 and 97.8±1.6, p<0.005. The reasons for non compliance are as follows:
Forgetfulness 61.5%
Adverse effects 25.3%
Wrong belief about treatment 8.8%
Not realizing that the treatment had been changed 6.6%
Others 2.2%
An article published from the general medicine division Palo Alto and Division of
clinical pharmacology, California about the Epidemiology of medicine –taking42
behavior states the rate of adherence increases if the number of doses per day is
less ie once daily around 60-90%, twice 50-80%, four times a day 30-70%.The report
has identified the barriers to adherence as Poor provider-patient communication,
Patient‟s interaction with the health care system and physicians‟s interaction with
the health care system.
According to a study on compliance and hypertension, the approaches to
compliance are patient demographics, medication characteristics, clinical factors,
health beliefs and the quality of patient provider communication. They have also said
that clinicians can increase compliance by assessing their patients stage of behavior
change and matching the intervention to that stage.43
An article „Does a positive attitude help when your chronic illness becomes worse‟44
states that Positive attitudes towards treatment and relationships with family and
caregivers can effect the outcomes of treatments. Positive attitudes are necessary
when successfully dealing with the crisis effects of psychological issues that follow a
chronic illness. These issues include: self image, anger, control, dependency,
stigma, isolation, abandonment and death.
In a study conducted at a rural health institution, Nigeria45 during 2008-09, 240
hypertensives were surveyed on their knowledge, attitudes and practices on
hypertension and their impact on compliance with antihypertensive drugs. The
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results of the study were one hundred and fourteen patients (47.5%) were men and
126 (52.5%) were women, mean age was 48.8±13.2 years, mean systolic and
diastolic BP were 156.8±25.1 mmHg and 98.4±18.7 mmHg respectively. The study
also revealed that only less than half (47.1%) showed good knowledge of their
hypertension and 141 (58.8%) possessed good knowledge of their antihypertensive
drugs. It also found that knowledge of hypertension was better in women than in men
(59.3% vs 40.7%, p=0.014), compliance to medications was good in only 77 (32.1%)
of the patients. The reasons attributed to poor compliance in the study was: poor
knowledge of the disease and ignorance of the need for long-term treatment
(95,32.6%); high cost of medications (63, 21.7%); religious practices and cultural
beliefs (37,12.5%); adverse drug reactions (19, 6.5%); inadequate access to medical
care (18, 6.2%); and use of complimentary medications (60, 20.5%).
C. Everett Koop, MD, said, “Drugs don't work in patients who don't take them.” There
is a lot of evidence that patients are not taking their medications as prescribed. Lack
of medication adherence contributes to poor patient outcomes and billions of health
care dollars spent unnecessarily. The article on Promoting Medication Adherence in
Older Adults … and the Rest of Us by Barbara Kocurek (2010), reviews medication
adherence in the United States, common reasons for lack of adherence, and
strategies for improving medication-taking in patients. The article states that several
studies have been published looking specifically at medication adherence in people
with diabetes and that a recently published systematic review reports adherence
rates to diabetes medications varied from 31 to 87% in retrospective studies and
from 53 to 98% in prospective studies, difficulty with taking medications as
prescribed can occur in anyone and that research has shown it affects both males
and females of all ages and across the spectrum of education and socioeconomic
status. It also discusses that age itself has not been identified as a risk factor for
medication nonadherence and the results of one study found that patients who were
more likely to be nonadherent were actually < 65 years of age and had fewer
comorbidities. This article gives educating the clients as a suggestion to improve
patient compliance. 1
Low adherence with antihypertensives in actual practice: the association with social
participation – a multilevel analysis was a study done to examine whether low social
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participation is associated with low adherence with antihypertensive medication, and
if this association is modified by the municipality of residence.The study identified
1288 users of antihypertensive medication from The Health Survey in Scania 2000,
Sweden, The outcome was low adherence with antihypertensives during the last two
weeks. Multilevel logistic regression with participants at the first level and
municipalities at the second level was used for analyses of the data. The results of
the study were low social participation was associated with low adherence with
antihypertensives during the last two weeks (OR = 2.05, 95% CI: 1.05–3.99),
independently of low educational level. However, after additional adjustment for poor
self-rated health and poor psychological health, the association between low social
participation and low adherence with antihypertensives during the last two weeks
remained but was not conclusive (OR = 1.80, 95% CI: 0.90–3.61). Furthermore, the
association between low social participation and low adherence with
antihypertensives during the last two weeks varied among municipalities in Scania
(i.e., cross-level interaction). The study concluded that low social participation seems
to be associated with low adherence with antihypertensives during the last two
weeks, and this association may be modified by the municipality of residence. Future
studies aimed at investigating health-related behaviours in general and low
adherence with medication in particular might benefit if they consider area of
residence.46
In the study done at new Delhi on Drug utilization of oral hypoglycemic agents in a
university teaching hospital in India Patients with established type 2 diabetes
(n = 218) visiting the OPD and IPD were interviewed using a structured
questionnaire during the period January–May 2006. The study aimed to determine
the drug utilization patterns in type 2 diabetic patients on oral hypoglycemic agents in
the Medicine Outpatient Department (OPD) and Inpatient Department (IPD) of
Majeedia Hospital, a teaching hospital of Hamdard University, New Delhi. They
found that a majority of the type 2 diabetic patients in this setting were treated with
multiple antidiabetic drug therapy. The most commonly prescribed antidiabetic drug
class was biguanides (metformin) followed by sulphonylureas (glimepiride),
thiazolidinediones (pioglitazone), insulin and alpha-glucosidase inhibitors (miglitol).
As monotherapy insulin was the most common choice followed by metformin. The
most prevalent multiple therapy was a three-drug combination of
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glimepiride + metformin + pioglitazone. More than half of the type 2 diabetic patients
showed poor adherence (compliance) to the prescribed therapy. Clinical monitoring
of patients' adherence to prescribed treatments is recommended and measures
should be taken to improve it.47
The reviews stated had helped to identify compliance as a global problem. The
Indian scenario could be assessed only by a few studies. It also helped to identify
that there were not many studies relating to compliance and family support or
compliance and previous health status.
Studies done with Morisky scale
The study on Self-Reported Morisky Score for Identifying Nonadherence with
Cardiovascular Medications48 reports that the Morisky medication adherence scale is
a commonly used adherence screening tool. It is composed of 4 yes/no questions
about past medication use patterns and is thus quick and simple to use during drug
history interviews. Forty-nine of 377 (13%) patients were categorized as non
adherent; however, only 12 (3%) patients had Morisky scores suggesting a high
likelihood of non adherence (3 or 4). While the Morisky score was a significant
independent predictor of non adherence by multivariate analysis, there was no
threshold score or individual question that yielded concurrent high sensitivity and
positive predictive values (PPVs) for identifying nonadherent patients. The internal
consistency of the questions was low (0.32), as were item-to-total score correlations,
suggesting that the individual questions were not measuring the same attribute.
A study on Factors affecting patient compliance with antihyperlipidemic medication in
a HMO population49 used prescription profile to assess their drug compliance. The
factors identified was patient characteristics, complexity of drug regimen, health
status and patient-provider interaction. Data was collected from 772 patients, 37%
complied with their treatment.The variables which showed significant influence were
female gender OR,0.64, baseline compliance-medium OR,1.86 (assessed using
Morisky scale) , perceived health status OR-SF-36 bodily pain score 1.02, SF-36
vitality score 0.97, comorbidity OR-0.90 and number of daily doses OR-0.60.
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A study on The Effects of Initial Drug Choice and Comorbidity on Antihypertensive
Therapy Compliance -Results From a Population-Based Study in the Elderly50 was
done among elderly patients 65 years and older. The study tried finding the effect of
initial drug choice and comorbidity on drug compliance. A retrospective follow up was
done of 8643 outpatients aged 65 to 99 with newly prescribed antihypertensive
therapy from 1982-88 in the New Jersey Medicaid and Medicare programs.
Compliance was measured in terms of the number of days in which AHT was
available to the patient during the 12 months following the initiation of therapy. Odds
ratios (OR) and 95% confidence intervals (CI) for the outcome of good compliance (
80%) were calculated.In a logistic regression model, good compliance ( 80%) was
significantly associated with use of newer agents such as angiotensin converting
enzyme inhibitors (OR 1.9, 95% CI 1.6 to 2.2) and calcium channel blockers (OR
1.7, 95% CI 1.5 to 2.1) as compared to thiazides, the presence of comorbid cardiac
disease (OR 1.2, 95% CI 1.1 to 1.2), and multiple physician visits (OR 2.2, 95% CI
1.8 to 2.5). Good compliance was inversely associated with use of multiple
pharmacies (OR 0.4, 95% CI 0.4 to 0.5) and number of medications prescribed
overall (OR 0.8, 95% CI 0.7 to 0.9).Drug choice, comorbidity, and health services
utilization were significantly associated with AHT compliance and represent
important considerations in the management of high blood pressure. Noncompliance
may be an important cause of treatment failure in elderly hypertensives.
A study to know the influence of patient‟s consciousness regarding high blood
pressure and patient‟s attitude in face of disease controlling medicine intake among
130 hypertensive patients. 35% had their blood pressure controlled, occupation and
duration of treatment were significantly related to controlled people. The assessment
with Morisky-Green scale has revealed that the question on neglecting the medicine
hours was associated with blood pressure control and the total score obtained by
77% of the participants was ≤3 which showed non adherence. 51
Why hypertensive patient‟s donot comply with the treatment52 was a qualitative study
and participants were identified as non-compliant based on Morisky-Green test. The
factors identified were medication, patient‟s beliefs and attitudes towards
hypertension and antihypertensives, physician, condition charecteristics. The study
was done at two primary health care centres of the Spanish National Health Service.
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They had done a telephonic survey among 267 hypertensive patients identified from
clinic and computer records to know their compliance status using the Morisky-
Green scale .146 patients who got a score ≥1 (this study has taken patients with
scores 2,3 and 4 for next phase of study to identify themes) were included for the
focus group discussion. The themes identified in the study were Medication(long
term use, more than one drug, taking every 24 hours, side effects, difficulty to
understand leaflets, leaflets seem frightening), Condition characteristics (chronic
conditions, well-being feeling), Patient‟s beliefs and attitudes towards hypertension
and antihypertensive (long-term use of anti-hypertensives is damaging, herbal or
natural remedies are effective for controlled high BP, disease is cured when high BP
is controlled, low adherence about treatment, risk factors, characteristics, and
complications of hypertension, most knowledge acquired by sources other than the
physician, drug-taking contingent to symptoms) and Physician (short time
consultation, doctor-patient interaction not encouraged, little time is spent regarding
information, information is provided mostly upon request by the patient, just a few
questions are asked, information provided is too general and not talked to the
individual, difficulty to understand physician‟s language or writing, eye contact is
rarely made during consultation, clinical encounter created nervousness).
Self-reported adherence with medication and cardiovascular disease outcomes in
the Second Australian National Blood Pressure Study (ANBP2)53 tried to investigate
whether responses to a previously validated four-item medication adherence
questionnaire were associated with adverse cardiovascular events. A postal survey
of medication adherence was undertaken by them in September and October
2000 of all 6018 surviving participants of the Second Australian National Blood
Pressure Study with Morisky instrument. 4039 older people with hypertension
responded to the postal survey. 2614 subjects were identified to adhere to
medication ie 67% ; those who adhered to their medication regimen (compared with
non-adherent subjects) were significantly less likely to experience a first
cardiovascular event or a first non-fatal cardiovascular event (hazard ratio [HR] for
both, 0.81; 95% CI, 0.67–0.98; P = 0.03); a fatal other cardiovascular event (HR,
0.68; 95% CI, 0.48–0.99; P = 0.04); or a first occurrence of heart failure (HR, 0.58;
95% CI, 0.37–0.90; P = 0.02). Those who answered yes to “Did you ever forget to
take your medication?” were significantly more likely to experience a cardiovascular
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event or death (HR, 1.28; 95% CI, 1.04–1.57; P = 0.02); a first cardiovascular event
or death (HR, 1.31; 95% CI, 1.07–1.60; P = 0.01); a first cardiovascular event (HR,
1.34; 95% CI, 1.09–1.65; P = 0.01); or a first non-fatal cardiovascular event (HR,
1.35; 95% CI, 1.09–1.66; P = 0.01). Those who answered yes to “Sometimes, if you
felt worse when you took your medicine, did you stop taking it?” were significantly
more likely to experience a first occurrence of heart failure (HR, 2.06; 95% CI, 1.16–
3.64; P = 0.01).
A study on Assessing Medication Adherence among Older Persons in Community
Settings states in 200554 that Medication adherence is an important public health
issue. To better understand its relevance among vulnerable populations requires the
availability of a valid, reliable and practical measurement approach. Researchers
have proposed various competing methods, including pill counts and self-report
measures. It had aimed at examining the utility of pill counts compared with self-
report measures in the assessment of medication adherence among older home
care clients. The study sample had included 319 home care clients aged 65+ years
randomly selected from urban and rural settings. They conducted the study during
in-home assessments; nurses had performed a medication review (including a pill
count), administered the Morisky self-report scale, obtained supplemental
information on medication use and completed the Resident Assessment Instrument
for Home Care (RAI-HC). Responses to the Morisky scale and an open-ended
question on nonadherence were combined to form a composite self-report measure
of adherence. The results showed that pill counts were either not feasible or
considered inaccurate for 34.7% of subjects (47.5% of all eligible drugs). For the 205
subjects with available pill counts, estimates derived from the dispense date were
found to underestimate adherence when compared with the actual start date
reported by clients. The Morisky scale showed low reliability (Cronbach‟s α=0.42)
and subjects‟ responses to the scale were often in disagreement with their
responses to the open-ended question on nonadherence. There was poor
agreement between the pill count and self-report measures.
Morisky tool was adopted in this study based on the review found above. The
description and classification given has enriched the present study also to identify
the compliance to drugs.
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Studies related to client education
The scope of the study Developing a generic, individualized adhernce programme
for chronic medication users55 was to describe the background for and content of an
adherence counselling programme with a specific focus on an individualised, multi-
dimensional adherence model for patients with a potential adherence problem (a so-
called individualized systems model).
An intervention programme based on WHOs systems model for adherence was
developed for implementation in primary health care and tested in a development
project in Danish pharmacies in 2004-2005 in three pharmacies and 4 GP practices
by 27 patients. Data were collected from the participants by registration forms,
questionnaires, and focus groups. Since the programme was to support patients in
the self-management process regarding choice and implementation of medication
treatment, various strategies were used and different theoretical assumptions and
choices made prior to setting up the study. These strategies include distinguishing
between different types of non-adherence, a model for stages of change, self-
efficacy, narratives, motivating interviewing strategies and coaching techniques. The
strategies and theoretical reflections formed the platform for the creation of a
counseling programme, which was tested in two forms, a basic and an extended
version - provided by either a pharmacologist or a pharmacist. Besides, the results
include a description of how the WHO-model is transformed into an individualised
counselling model. According to WHO, non-adherence should not be viewed as an
isolated, single-factor problem, but rather as a multi-dimensional problem not
determined exclusively by patient factors, as is seen most often in adherence
research. WHOs systems model aims to analyse and provide explanations for non-
adherence on a societal and health policy level in a broader sense.
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Fig-2 Five dimensions of adherence
The programme identifies potential non-adherence, analyses the character of the
problems identified, including drug-related problems, explores patient resources and
provides concordance-based follow-up sessions and individually based
interventions. The model developed and used as a template for the entire
programme was called the individualised systems model. It emerged from the
transformation of the WHO model into an individualised counselling model.
Fig-3 Individual system model
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According to a paper on Resourcing issues by Juan Jose´ Gagliardino 56diabetes is a
chronic, progressive disease and achieving appropriate control of glycaemia and the
other associated cardiovascular risk factors is essential to prevent its long-term
complications. Currently, recovery and rehabilitation from the cardiovascular
complications of diabetes are the major focus of diabetes care rather than primary
and secondary prevention of diabetes and its complications. This focus, coupled with
limited funding and other resource issues, means that diabetes care and outcomes
are generally suboptimal. More efficient and effective management strategies,
primarily based upon a broad educational approach including both those with
diabetes and their care-givers will be essential in reducing the cost of diabetes and
diabetes-related complications. Continuous education of patients and providers
increases the quality of care and improves clinical and metabolic outcomes as well
as reducing the cost of care and optimising human and financial resources. Thus,
education will be a key strategy in minimising the growing burden of diabetes on
society. Making these changes will require the co-operation of patients, their families,
the community, healthcare policy makers, national governments and the
pharmaceutical industry. Medical schools must also place more emphasis on
educating doctors about chronic disease management using not only recovery and
rehabilitation, but also prevention strategies, emphasising the importance of helping
patients to participate in the control of their disease.
Patients were allocated to control(114) or intervention group(118) in the study on
Improving medicine usage through patient information leaflets in India conducted at
tertiary care public health facility in India. The patients in the intervention group got
information leaflet and the primary indicators improved significantly in the
intervention group compared with the control (15.7±7.3 versus 12.2±5.4) p<0.01.
Confounding variables ie age, sex, literacy level did not influence the patient‟s
knowledge.57
In a study on assessment of impact of medication counseling on patients‟ medication
knowledge and compliance in an outpatient clinic in South India explains that there is
an improvement in the compliance among the group of patients who were counseled
against the usual care group.(92.29±4.5 and 84.71±11.8) p value is not mentioned in
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the study. Knowledge level of the counseled group also showed an improvement
(13.82±1.8604 and 11.78±3.5037).58
A study on the Effectiveness of a Hypertension Educational Program on Improving
medication compliance in Shiraz, 200459 concludes that mean score of compliance
was greater after the education program (4.16 vs 2.66, p<0.05). 150 non compliant
hypertensive patients were selected and direct educational interview on how to
handle drugs was given to them in the clinic then they were divided into 4 groups
and educated through telephone consult, telephone consult and educational booklet,
educational booklet and on education. The study concludes that direct education
based on patient‟s problems is effective in improving compliance. It also
recommends that large studies are needed to differentiate between various methods.
The Working paper no. 10460 on Prevention and control of non-communicable
Diseases: status and strategies published by Indian council for research on
international economic relations estimates the prevalence of Diabetes mellitus as 13
million ie 1.3% of total population and Heart diseases (IHD, HT, Stroke, RHD)
Prevalence 65 million ie 6.6% by 1998. It also discusses that the constraints of
limited health care provider resources may be overcome by investing in patient
education and encouraging self-care which will reduce the demands of follow-up
care. The need for promoting participatory care through patient education and the
value of promoting self-monitoring and self-care in improving outcomes have been
recently acknowledged in the developed countries. From the introduction of patient
education packages for hypertension and congestive heart failure to the outstanding
success of diabetes self-care, these practices have served to alter the provider
dominated paternalistic model of care in favour of a partnership model of patient
participation. While planning the organisation of health services, the goal should be
to shift the centre of gravity of chronic care delivery progressively towards the base
of the health care pyramid. By strengthening the capacity for care by self, family,
community, paramedic, or traditional healer and by encouraging guidelines based
practice and a rational referral-follow-up pattern which obviates the need for frequent
revisits to secondary and tertiary care providers, the responsibility for delivering
chronic care devolves downwards closer to the community and away from the more
expensive and less accessible higher health care stations. Only such a shift can
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ensure a sustainable system of chronic care in India, with the promise of extended
coverage and containment of costs.
Usha Malagi, Rama Naik and Ramesh Babruwadin61 their study on Knowledge
Practices and Life Style Factors of Type - 2 Diabetics has found that the life style
factors such as foods restricted and specially included, vices prevalent, exercise
behavior and knowledge and practices of 50 type-2 diabetics were assessed using a
pretested structured questionnaire. Diabetics restricted the foods such as rice, roots
and tubers, sweets and fruits. The foods were specially included for the management
of disorder by majority of diabetics (72%). Salads, green leafy vegetables, bitter
gourd, ragi and spices such as fenugreek were specially included foods. The vices
practiced by men were smoking (14%), drinking alcohol (48%) and tobacco chewing
was seen in very few men and women. Exercise was done by half of the diabetics
(56%) and half of the exercising subjects had started exercise only about a year
back. About 30% of diabetics had poor knowledge scores and 16% diabetics had
poor diabetic practice scores. Thus, the diabetics need education to improve the
knowledge and practices for the proper management of disorder.
A study on Efficacy of a home blood pressure monitoring programme on therapeutic
compliance in hypertension: the EAPACUM-HTA study62 was conducted at 40
primary care centres in Spain, with a duration of 6 months. A total of 250 patients
with newly diagnosed or uncontrolled hypertension were included. They were given
an electronic monitor for measuring compliance (monitoring events medication
system). MEMS is an electronic device which records the date and times of bottle
cap openings as a means of assessing adherence. Compliance observed was 74%
and 92% in control group and intervention group (95% CI 81.2-94 and 80.7-
98.3;p=0.0001). The number need to treat to avoid one case of noncompliance was
5.6 patients. The programme was found effective in improving compliance in arterial
hypertension.
The cited review indicates that teaching does form an effective way to improve
compliance in the clients. It gave an insight to use both formal and non formal ways
of teaching to improve compliance which is adopted in this study.