Syddansk Universitet Development of RehApp - an

Syddansk Universitet

Development of RehApp - an information and communication technology assistedintervention at home for patients with cervical radiculopathy based on principles froman innovation modelRasmussen, Hanne; Boyle, Eleanor; Kongsted, Alice; Manniche, Claus; Sjøgaard, Gisela;Kjaer, Per

Publication date:2016

Link to publication

Citation for pulished version (APA):Rasmussen, H., Boyle, E., Kongsted, A., Manniche, C., Sjøgaard, G., & Kjær, P. (2016). Development ofRehApp - an information and communication technology assisted intervention at home for patients with cervicalradiculopathy based on principles from an innovation model.

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http://findresearcher.sdu.dk/portal/en/publications/development-of-rehapp--an-information-and-communication-technology-assisted-intervention-at-home-for-patients-with-cervical-radiculopathy-based-on-principles-from-an-innovation-model(e399eadf-f461-4185-93f0-3c2f80ecf8c3).html

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www.patientathome.dk

DevelopmentofRehApp-aninformationandcommunicationtechnologyassisted

interventionathomeforpatientswithcervicalradiculopathybasedonprinciples

fromaninnovationmodel

Authors:HanneRasmussen12,EleanorBoyle13,AliceKongsted14,ClausManniche2,Gisela

Sjøgaard1,PerKjær12,

Affiliations1DepartmentofSportsScienceandClinicalBiomechanics,UniversityofSouthernDenmark,

Odense,Denmark

2TheSpineCentreofSouthernDenmark,LillebaeltHospital,Middelfart,Denmark

3DallaLanaSchoolofPublicHealth,UniversityofToronto,Toronto,Canada

4NordicInstituteofChiropracticandClinicalBiomechanics,Odense,Denmark

Context

TheframeworkforthisprojectisalargeWelfareTechnologyProjectentitled“Patient@home”

thatseekstopromoterehabilitativetrainingathomeinordertoreducethecostsof

hospitalization,transportation,improvepatienthealthcareandreducetheuseofhealthcare

services.ThedevelopmentoftheRehAppprojectwasdoneincollaborationwithresearchersfrom

theDepartmentofSportsScienceandClinicalBiomechanicsattheUniversityofSouthern

Denmark;engineersandstudentsfromTheMaerskMcKinneyMollerInstitute;thecompany

ExorLive;andcliniciansandpatientsfromtheSpineCentreofSouthernDenmark.Theworkhas

beensupportedbygrantsfromTheStrategicResearchCouncil,TheCouncilforTechnologyand

Innovation,andVækstforumFyn.

Odense30thOctober2015

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WorkinggroupinPatient@home

HanneRasmussen,AliceKongsted,GiselaSjoegaard,EleanorBoyle,AnneMarieRosager,Berit

Schiøttz-Christensen,ClausManniche,UlrikPaghSchulz,KennethKristensen,MaziarTaghiyar-

Zamani,JørgenBondy,PerKjaer(workpackageleader).

WorkinggroupattheSpineCentre

PerKjaer,HanneRasmussen,BeritSchiøttz-Christensen,ClausManniche

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Index

Overallbackgroundandaim......................................................................................................................5

Theinnovationprocess.............................................................................................................................6

Need..............................................................................................................................................................9

Screeningofliteratureandbestclinicalpractice.....................................................................................9

DescriptiveandqualitativestudiesofpatientswithCR.........................................................................10

ScreeningTechnology.............................................................................................................................10

Concept.......................................................................................................................................................11

Partneridentification.............................................................................................................................11

Ideageneration......................................................................................................................................12

Mock-upsofprototypes.........................................................................................................................14

Testingandadjusting..............................................................................................................................16

Proofofconcept..........................................................................................................................................25

Backgroundandaimsofthefeasibilitystudy.........................................................................................25

Methods.................................................................................................................................................27

Dataanalyses..........................................................................................................................................30

Results....................................................................................................................................................32

Discussion...............................................................................................................................................38

Conclusion..............................................................................................................................................41

References..............................................................................................................................................42

Appendix1..............................................................................................................................................44

Interviewguide(patients)...........................................................................................................................44

Appendix2..............................................................................................................................................45

Interviewguidetiltestaf’Reh-app’(Kliniker)..............................................................................................45

Klinikerinformationogspørgsmålom’Reh-app’...................................................................................45

Appendix3..............................................................................................................................................46

Resultsofthepatientinterviewstheconceptphase..................................................................................46

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Appendix4..............................................................................................................................................48

Resultsfromfocusgroupinterviewwithhealthcareprofessionals............................................................48

Appendix5..............................................................................................................................................51

SpørgeskemaomRehApp...........................................................................................................................51

Andrekommentarer:...................................................................................................................................54

Appendix6..............................................................................................................................................55

Summaryofsuggestionsandrecommendations........................................................................................55

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Overallbackgroundandaim

Itisestimatedthatbetween8,000and10,000Daneseveryyearexperiencearmpainoriginating

fromtheirneck(ref).Thispainmaybetheresultofpressureonthenerverootbyaherniateddisk

ordegeneratedjointsintheneck.Theconditionisknownascervicalradiculopathy(CR)[1].About

aquarterofthepatientswithCRarereferredforsurgery.Whilethevastmajorityareoffered

patienteducationandexercisetherapy[2].Weknowthatexerciseshaveapositiveeffecton

patientswithnon-specificneckpain,butintermsofpatientswithCR,wedonotknowwhichtype

ofexerciseisthemosteffective[3].

DuetotheseverityoftheCRsymptomsandtheassociatedpain-relatedactivitylimitation[4-6],

patientswithCRneedmonitoringandguidanceaspartoftheircaretodetectworsening,to

preventdevelopmentofchronicpain,andimproverecovery.Insomepatients,suddenworsening

oftheconditionrequiresfastmedicalattentionthatmayresultintheneedtoconsultwithaspinal

surgeon.Also,itseemsvitalthatpatientsexperiencecontrolovertheirownsituationandareable

tomaintainanormallife.Sincetheacutephaseisgenerallycharacterizedwithseverepain,

patientsmightbehinderedinseekingtimelyhealthcarebecauseoftheirinabilitytotraveltoa

healthcareprovider.Itisthereforerelevanttoidentifyandtestnewapproachesandstrategiesto

improvethehealthcaremanagementforthispatientgroup.Atthesametime,thereisan

increasingdemandinDenmarkandinWesterncountriesforinterventionsforcommonconditions

thatarelessexpensiveandrequirelesshealthcarepersonnel.

Theuseofinformationandcommunicationtechnology(ICT)suchastelemedicinehasbeen

implementedforavarietyofdifferentconditionssuchas,heartfailure[7],chronicobstructive

pulmonarydisease[8]anddiabetes[9].ICTassistedinterventionsathomemightbebeneficialfor

patientswithCR,sinceitwouldbepossiblemonitortheirsymptoms,introducemonitoringand

interventionsforCRthatsupportpatientsinbeingabletomanagetheirconditionfromtheir

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home.Inaddition,thismayreducetheneedofservicesfromthehealthcaresystemandatthe

sametimedetectworseningthatrequiresimmediatemedicalattention.

TheoverallaimofthisprojectwasthereforebyinnovativeprocedurestodevelopandtestanICT

assistedinterventionthatcouldimprovehealthcaremanagementforpatientswithCRinan

effectiveway.

Theinnovationprocess

Patient@homeworksaccordingtoaninnovationmodelthatformsthebasisoftheproductsand

servicesbeingdevelopedintheproject.Theinnovationmodelhasfivephases:1)Requirement

/Needassessment;2)Conceptdevelopment;3)Proofofconcept;4)Products/Services

development;5)TestingandEvaluation(seeFigure1).Dependingontheindividualinnovation

process,thevariousphasescanbeofdifferentlengthsandcontainmore,less,orotheractivities

thantheoneslistedinFigure1.

Theinnovationprocessmaystartatdifferentstages.However,ingeneral,allinnovationprojects

startnolaterthanphase4(Product/Services)inordertomakeroomwithintheprojectperiodfor

testingandadaptationofthesolutioninquestion.Basedonthisinnovationmodel,aprototypeof

anapplicationforpatientswithcervicalradiculopathywasdevelopedandtestedinafeasibility

study.ThegeneralprocessesintheinnovationandfeasibilityprojectisillustratedinFigure2.

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Figure1.TheInnovationModelfromPatient@home

.

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Need

1. LiteraturereviewsClinicalbestpracticeGuidelines

2. LongitudinalandQualitativestudiesofpatientswithCR

3. ScreeningofICT

ConceptPartneridentification

Ideageneration

Mock-ups

TestingandadjustingofICT-intervention

ProofofconceptTestofaprototypeofRehAppinafeasibilitystudy

Product/serviceDesignandconstructionofafinalversionofRehAppasanICTintervention

TestandevaluationTechnologyassistedinterventionathomeforpatientswithCR:

Arandomizedcontrolledtrial

Figure1.TheinnovationprocessinthedevelopmentofRehApp.

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www.patientathome.dkwww.patientathome.dkwww.patientathome.dkwww.patientathome.dk

Need

Thedemandsandneedsfordeveloping/optimizingtreatmentapproachesandcaremanagement

strategiesforpatientswithCRwereidentifiedby:1)screeningofliteratureregardingdiagnostics

[10,11]andtypesoftreatment[3],discussionofbestclinicalpracticewithresearchersinthe

interdisciplinaryworkinggroupinPatient@home,cliniciansattheSpineCentreofSouthern

Denmarkandthroughparticipationindevelopinganationalclinicalguideline[12];2)description

ofthepatientcohortusingalongitudinalobservationalstudy[4]andusingtwoqualitativestudies

consistedofaninterventionmappingstudyattheSpineCentre[13]andamaster’sthesisabout

the“livedexperience”forthepatient[14];and3)screeningofICTtechnologyincollaboration

withresearchersandengineers.Thistookplaceduringtheperiodfrom2013to2015.Following

needsandrequirementswereidentified:

Screeningofliteratureandbestclinicalpractice

Diagnostics

Thescreeningoftheliteratureshowedtherewasavarietyindiagnosticcriteriaandtheywereall

poorlydescribed[10].Inanunpublishedliteraturereviewofthediagnosticvalueofprovocative

andneurologicaltestsitwasfoundinafewandveryheterogeneousstudiesthatneurological

tests(specificallytestsforrefleximpairmentandmuscleweakness)incombinationwithpatient

historyandotherphysicalfindings,maybethemostoptimalmethodofdiagnosingCR[15].

Treatment

TherewereafewstudieswithlowevidenceofeffectiveinterventionsforCR[3].Indiscussions

withresearchersandclinicians,itwasrecognisedthatthemainfocusinbestclinicalpracticefor

patientsexperiencingsignsofCRwereinthefirstphaseoftheconditiontoinformaboutthe

condition,guidethepatientinrelationtoappropriatecopingstrategies,andexercisesand

activitiesthatwouldnotincreaseradicularpainandsymptoms.Inaddition,individualexercises

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withfocusonposture,neuromuscularanddirectionalpreferencescouldberelevant.Thiswasalso

emphasizedintheDanishnationalclinicalguidelinesforCR[12].

DescriptiveandqualitativestudiesofpatientswithCR

TheobservationalstudyofpatientswithneckpainwithandwithoutCRwasconductedinthe

SpineCentreofSouthernDenmark.Atthefirstvisit,CRpatientshadthemostsevereprofile

amongallneckpainpatients.TheCRpatientgrouphadmorepain,increasedreportingofsick

leaveandmorepain-relatedactivitylimitation[4]comparedtoothertypesofneckpainpatients.

Thesefindingsunderpintheneedforidentifyingandtestingeffectiveinterventionsthatcan

addresstheseproblems.Intheinterventionmappingstudy,qualitativefocusgroupinterviews

wereconductedinpatientswithCR.Someofthemajorandrepeatedconcerns/commentsfrom

thepatientswereaboutbeingmoreinvolvedintheirowncare,receivingmoreeducationontheir

conditionandachieveagreaterdegreeofunderstandingfromtheoutsideworld[13].Theresults

fromthemasterthesis:‘The'un-just'Factor:BalancingLifeintheLivedExperienceofCervical

Radiculopathy’-aqualitativestudyofpatients’experiences,revealedsimilarcommentsand

concernsasintheinterventionmappingstudy.Inaddition,patientsexpressedincreasingsenseof

feelingisolatedandnotconfidentoranxiousabouttheirsituationandcondition.

ScreeningTechnology

Basedontheidentifiedneeds,thechallengewaswhetherornotresearchers,engineersand

companieswerecapableofdevelopinganddeliveringICTtechnologythatwasableto:monitor

patientprogress,deliverinformation,guideexerciseandregisterdataforfeedbacktotheuseras

wellasforresearchpurposes.ScreeningofthemarketforICTtechnologyandmeetingswith

developersofICTwasinitiatedtoidentifyanICTsolutionthatcouldsupportthis.

Inthisprocess,severalICTtechnologiessuchasexerciseapplications,softwareprograms,sensors

forbiofeedback,web-based-videoplatforms,headsets,elasticrubberbandswithsensorswere

presentedanddiscussedatmeetingsbetweencompanies,engineersandresearchers.The

collaboratorsinthisphasewereengineers,researchersandstudentsfromMaerskMcKinney

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MoellerInstituteattheUniversityofSouthernDenmark,andsmalltomediumsizeenterprises

suchasDigimovez,MobileFitness,iCura,DorsaVi,SportsSensor/BandizerandExorLive.

Concept

Inthisphaserelevantcollaborators/partnerswereidentifiedandpartnershipswereformed.Time

andfinanciallimitationsweretakenwerealsotakenintoaccount.

Ideagenerationbasedontheidentifiedneedsandrequirementsinthefirstphaseformedthe

conceptandthefirstmock-upsofprototypesoftheICTintervention.

Auser-involvediterativeprocesswithdeveloping,testingandcollectingfeedbackandresponses

onmock-upsandprototypesofdifferentversionsoftheRehApptookplacefromJanuarytoApril

2015.

HanneRasmussen(HR),physiotherapistintheSpineCentreandresearchassistantintheproject

wasinchargeofconductingthetestsandinterviews.

Partneridentification

ApartnershipevolvedbetweentheDepartmentofSportsScienceandClinicalBiomechanics,

Exorlive,andengineersandstudentsfromMaerskMcKinneyMoellerInstitutetodevelopaweb-

basedapplicationplatformwiththeoptionofaddingotherICTsupportedinterventions.A

partnershipwiththeSpineCentreofSouthernDenmarkwasformedinordertogiveaccesstothe

potentialusers(patientsandclinicians)oftheICTintervention

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Ideageneration

Intervention

Theresultoftherequirement/needphasewasaneedfordevelopinganICTsupported

interventionthatcouldmeetpatient-expressedneedsintermsofinformationandeducationina

waythatthepatientwouldfeelinvolvedwiththeirhealthcareandfeelconfidentinhandlingtheir

condition.Itshouldbealignedwithscientificevidenceinliterature,expressedfocusareasfrom

bestclinicalpracticeandrecommendationsfromtheclinicalguidelines.Finally,theICTsupported

interventionwouldneedtobecapableofcollectinginformationaboutthecourseofCRand

responsestothetreatmentstrategies.Basedonthisitwasdecidedtodevelopaweb-based

applicationplatformwiththeoptionofaddingotherICToptions.Theapplicationwasnamed

RehApp.

ThebasisfordevelopingtheprototypeofRehAppwasaclinicaldecisionalgorithmdevelopedin

collaborationwithresearchersattheDepartmentofSportsScienceandClinicalBiomechanics.

Basedonknowledgeaboutthispatientgroup,itwasdecidedthatinthemoresub-acutephase,

exercisesshouldbegeneralandcardiovascular-relatedtypeasthiswouldallowthepatienttostay

fairlyactiveandmaintainphysicalfitnesswithoutworseningtheirpainorCRsymptoms.Ifthe

patienttoleratedthis,morespecificexercisesandactivitieswouldbeinitiated(Figure3).

Therefore,theoriginalintentwastodevelopanapplicationthatbasedonthepatient’spainlevel

andseverityofnerverootsymptomswoulddirectthepatienttothemostappropriateactionor

exercise.Whenapatientreportsincreasingpainintheirarm,theywouldbeadvisedtostopdoing

theircurrentexercisestrategyandadifferentexercisestrategywouldberecommendedand/ora

painrelievingpositionswouldberecommended.Ifthearmpaincontinuedtoincreaseoveratwo

dayperiodand/ortheydevelopedsevereworseningoftheconditionintermsoflossofstrength

andsensitivityinthearmorlegs,orlossofcontroloverbladderandbowelfunction(so-calledred

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flags)(needtofinishthethought).IfthepatientfeltthattheirCRsymptomshadimproved,they

wouldbeadvisedtoprogresstheirexercisesandactivities.

Figure2.Clinicaldecisionalgorithmforindividualizedexercisetopatientswithcervicalradiculopathy

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Outcomemeasures

Itwasdiscussedwhichmethodstousefortestingthefeasibilityandpotentialeffectsofthe

intervention.Inrelationtothis,theuseofindividualandgroupinterviewsandquestionnaires

relatedtorelevantpatientoutcomessuchaspainandfunctionweresuggested

Inrelationtorelevanttestmethods,developmentofinterviewguidesforinterviewswithpatients

andcliniciansandaquestionnaireforuseinthefeasibilitystudywereplanned.Itwasalsodecided

toexplorethepossibilityandvalueofaddingquestionnairesaboutdisabilityinarm,shoulderand

handandpain(DASH)[16]andpainself-efficacy(PSEQ)[17]totheroutinecollectionofpatient

demographicsandbio-psycho-socialprofilesfromtheSpineDatadatabaseusedattheSpine

Centre.

DesignofinterviewguidesandtheRehAppquestionnaire

Interviewguidesforpatientsandclinicianswerepreparedbasedonknowledgefromthe

interventionmappingstudyandinputfromresearchersattheDepartmentofSportsScienceand

ClinicalBiomechanicsattheUniversityofSouthernDenmark.TheRehAppquestionnaireforthe

feasibilitystudywasdevelopedbasedontheresponsestotheinterviewguideduringthetesting

oftheRehAppprototypes.

Mock-upsofprototypes

TheprototypeRehAppunderwentadjustmentsandchangesaccordingtoinputfromtheusers,

cliniciansandresearchers.Theseinputsandsuggestionswerediscussedatmeetingsbetween

researchersfromtheDepartmentofSportsScienceandClinicalBiomechanics,ExorLiveand

engineersfromtheMaerskMcKinneyMoellerInstitute.Ifrelevant,inrelationtotheidentified

needsaswellasrealisticandfeasiblewithinthebudgetandtimeframe,theadjustmentstothe

applicationweremadebytheengineers,studentsandHR.

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3versionsofprototypesoftheRehAppweretestedinasampleofpatientsaged18yearsormore,

hadaleastoneclinicalsignofcervicalnerverootcompromise,painequaltoorabove3on

numericpainratingscale(0-10)inoneoftheirupperextremities[18]andwereableto

understand,speakandreadDanish.ThepatientswereinvitedtotestRehAppattheirfirstvisitto

theSpineCentre.HRintroducedconsentingpatientstotheRehApp.Theyweregivenverbalas

wellaswritteninformationandguidance.ThestudywaspresentedforTheRegionalCommittees

onHealthResearchEthicsforSouthernDenmarkanddidnotrequireapproval(project-IDs-

201130116).TheparticipantsusedtheRehAppathomeforthefollowingtwoweeks.Theycould

contactHRortheSpineCentrebyphoneduringtheentiretestperiodincaseofproblemswiththe

applicationorworseningCRsymptoms.Participantswereinvitedbackattwoweeksforasemi-

structuredinterviewabouttheiropinionsoftheRehApp(Appendix1).Theinterviewswere

performedbyHRandwereaudiotapedandlaterontranscribed.

ThefirstprototypeofRehAppwaspresentedtoamultidisciplinarygroupofclinicians.HR

demonstratedtheprototypeforthecliniciansandtheyweregiventheoptionoftestingbefore

andafterthepresentation.Asemi-structuredfocusgroupinterviewwasperformedbasedonan

interviewguide(Appendix2).

Inaddition,thefirstandlastversionofprototypeswerepresentedtoallthestaff,aspartthe

routinelyupdatingonprojectsintheSpineCentre,atamorningconferenceinthebeginningand

endoftheprototypedevelopment.Itwasonthoseoccasionspossibleforeveryonetomake

commentsandsuggestions.

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Testingandadjusting

Userinvolvement(patients)

Atotaloffivepatients,threewomenandtwomen,agerangedbetween45and59years

participatedintestingofthethreeprototypesofRehApp.

Theanswersandresponsesfromthefiveinterviewsaresummarizedinthefollowingcategories

(Appendix3):

1. Overallassessment

Ingeneral,allpatientsexceptonepatientwerepositive.

Followingfeedbackwasexpressed:

• Itwasnicethatyoucoulddotheexerciseswhenandwhereyouwanted

• Helpfulthatyoucouldreadandseetheexercisesinadrawingoravideo

• Itwouldhavebeennicewithmorespecificexercisesfortheneck

Quotefromapatient‘itwasmorelikeawarm-upexercise-passforasoccerteam…’

2. User-friendliness

IngeneralallfoundthedesignofRehAppwaslogicandeasytounderstandbutsometimesalittle

difficulttooperate.


• Sometimeshardtologin

• Needformoreflexibilityintheexerciseprogram

Quotefromapatient:‘Annoyingthatyoucouldn’tignoreanexerciseandgotothenextoneorgo

back’

3. Positives

Ingeneral,patientsexpressedpositiveexperienceswiththeRehApp.

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• Theapphelpedwithgainingmoreknowledgeabouttheconditionandhowtohandleit

• Ithelpedwithunderstandingexercisessinceyoucouldreadandwatchvideosandrepeat

it.

• Itallowedforflexibilityinwhereandwhentodoexercise.

• Itsavedtimeandmoneysinceyoudidn’thavetotaketimeofffromworkandspenttime

andmoneyontransportationtotheclinic.

• Ithelpedmetobetterunderstandtheexercisesandtoremembertodothem

4. Deficiencies

AllfivealsomentionedtheneedforanaudiooptionintheRehAppthatwouldmakeitpossibleto

listentoinstructionsasanalternativeorsupplementtothewritteninstructions.


• Optionsofbeingabletogobackandforwardsorskiponeoftheexercisesifneeded

• Optionofdrawingwherethepainwas

• Receivingremindersabouttimeforexercise

• Atypeofexercisedairywhereyoucouldalsoseepainlevels

• Moreinformationaboutmycondition

5. OtherSuggestions

• Abilitytochatwiththeclinicianorotherpatientswouldbenice

• Optionofuploadingphotosorvideosforfeedback

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Userinvolvement(clinicians)

Sevencliniciansincludingtwophysiotherapists,onechiropractor,onephysicianandtwonurses

participatedinafocusgroup.Theanswersandresponsesfromthefocusgroupweresummarized

inthefollowingcategories(Appendix4):

1. Relevance

Everyoneagreedthattheuseofanapplicationwouldberelevantandhelpfulforthispatient

population

Quotefromoneoftheclinicians:‘Itwouldbehelpfulforpatientsthatlivefarawayfrom

theSpineCentreandareworking,theywouldbeabletohandletheirsituationfromhome

includingdoingexercisesinsteadofspendingtimedrivingtothespinecentre’.

2. Requirements

SomeoftherequirementsoftheRehAppwerethatitshouldbeverysimpletousewithshortand

clearinformation.Preferablywithminimaltextanduseofsymbolsinsteadoftext

Quotefromoneoftheclinicians:‘Importantwithasimpletechnologyandclearinformationto

minimizemisunderstandingsandmisinterpretationofexercisesandguidelines’.

3. Challenges

Itwasstateditmightnotbeappropriateforallpatientgroupsduetolackofknowledge/familiarity

withICTtechnology,languageandotherpsychosocialbarriers,butatthesametimethesepatients

wouldalsobethosewhocouldbenefitfromaninexpensiveintervention,wheretheydidnothave

topayforvisitsataclinicinprimarycare

Quotefromoneoftheclinicians:‘Itisnotforallpatients,somedonothaveexperienceandskills

withtheuseofICTtechnology.Somehaveissuesandproblemsthatcannotbehandledinanapp’.

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4. Concerns

Themajorconcernamongtheclinicianswastheriskofthepatientdevelopingmoresevere

symptomsthatwouldgounnoticedbythem.

Quotefromoneoftheclinicians:‘Iwouldbeconcernedofdevelopmentofatrophywithout

noticingontime.Communicationanddialogwithotherpatients,whichseemtobeimportantin

thegroupexerciseprogram’.

5. Impactonclinicalpractice

Everyoneagreeditwouldbeadifferentwaytowork,whereyouwouldhavetochangesomeof

theclinicalproceduresandlogistics.Itcouldalsoprobablyimprovethetreatment

Quotefromoneoftheclinicians:‘Itwouldmakeiteasierandprobablyimprovetreatmentsince

youwouldbeabletomonitorandmodifyinitiatedexerciseprogramsandadvices’.

6. Themostimportantcontentsoftheapp

ItwasemphasizedthattheRehAppshouldbeabletoguidethepatientnotonlybasedonpainand

symptoms,butalsobasedontheirindividualgoals.Inaddition,theRehAppshouldbeableto

tailortheactivitiesthatareimportanttothepatient

Quotefromoneoftheclinicians:‘Importantwithindividualgoalsettingatbaselinethatwould

guidechoiceofexercisesandactivities.Itshouldalsobepossibletoadjustgoalsandactivities/

exercisesifneededduringthecourseoftreatment/rehabilitation’.

7. Mostimportantoutcomesoftheuseoftheapp

Thefocusamongtheclinicianswasonwork-relatedoutcomes,suchasback-to-workandnumber

ofdaysonsickleave.

Quotefromoneoftheclinicians:‘Sincethisconditionhasagreatimpactonthepatientbutalsoon

expensesinsociety,Iwouldthinkitwouldbeimportanttopicksomeoutcomessuchasbackto

work/sickleavethatareimportantforboththepatientandsociety’.

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Overallfeedbackfromcliniciansatthespinecentre

ThefirstandlastprototypesoftheRehAppwerepresentedtoallcliniciansatmorning-

conferenceswhereeveryonecouldgivetheirimmediatefeedback.Therewereonlyafew

responsesmainlyduetolimitedtime,butimportanceofselectingtherightpatientforthe

applicationandthatthereshouldbeaformofdiaryforthepatientintheapptoassistthepatient

werebroughtup.

RehAppquestionnaire

Basedonresultsfromtheinterventionmappingstudy,interviewresponsesfromthefivetest

patientsandinputfromthemeetings,aRehAppquestionnairewith12questionsaboutfeasibility,

userfriendlinessandrelevancewasdeveloped(Appendix5).

ThetechnicaldevelopmentofRehApp

ThedevelopmentofRehAppwentthroughseveraladjustmentsbasedontheaboveinputand

afterdiscussionswithpartnersandresearchersintheproject.Thisresultedinfourversions.

Wherethefirstversionwasamock-up,justforexemplifyingandthefollowingthreeversionswere

theonesthatweretestedamongtheusersandleduptothefinalprototypeofRehApp.

1. Version

Thefirstversionwasasimplemock-upthatwasdevelopedtobeabletodecideonthevisual

designandthesetupofthecontents.Incollaborationwithengineerstudents,RehAppwas

developedusingadecisionalgorithmthatmatchedaclinicalalgorithm(Figure3).Thisresultedin

theabilitytohavethepatient’slevelofpainguidewhichinterventionstrategywouldbemost

appropriateforhim/her.Itwasalsodecidedtoregistergripstrengthinordertomonitorand

registerpotentialworseningofthecondition

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2. Version

Version2wassimplifiedcomparedtoVersion1.Thepatientwouldinputtheirpainlevelandgrip

strengthwhentheyfirstusedtheapplication.Thepatientwouldcontinueinputtingtheirpain

levelandRehAppwouldrecommendwhatexercisestodo.Ifpainlevelincreasedbymorethan2

numbers,RehAppwouldsuggestpain-relievingpositionstothepatientandcontacttheSpine

Centreiftherewasstillanissuewiththeirpainlevel.Patientswereaskedtomonitortheirgrip

strengthdailybyusingadynamometerathomeandentertheresultintheapp.RehAppprovided

informationabout‘redflags’(significantdecreaseinupperextremitystrength,lossofsensation

and/orbladderorbowelsymptoms)andhowtorespondtothese.Thepatientwasadvisedto

eitherusethecardioexerciseprogramintheapplicationorgoforawalk2-3timesadayfor20

minutes.Theillustrationsofthecardio-exercisesandpainrelievingexerciseswerecopiedfrom

theExorLiveexerciseplatformwithpermissionfromcompanyExorLive.(Figure4)

Figure3.RehAppversion2

3. Version

Optionsofaudioandvideoinrelationtoexerciseswereadded.Aninformationpamphletabout

CRandavideopodcastaboutCRwereaddedtoRehApp.Italsobecamepossibleinthisversionfor

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thepatientandcliniciantoseeahistoryofthepainlevelsandcompletedexercises.Monitoring

gripstrengthwasdroppedbecauseitrequiredanextraeffortfromthepatienttodothe

measurementandentertheinformationtoRehApp.Italsodidnotaddmorerelevantinformation

formonitoringtheredflagsthatcouldnotbeidentifiedalreadybytheredflagsinfointheapp

withwarningandinformationaboutcontactingtheSpineCentre(Figure5).

Figure4.RehAppversion3,Painandexercisehistory.

4. Version

The4thversionwasthefinalprototypeofRehApp.Itwasaweb-basedapplicationthatcouldbe

usedonPCs,smartphonesandtablets.Theapplicationconsistedoftwosystems:

1) Acustomizedfront-endthatcouldprovidetheabilitytodothefollowingtasks:

a. Registerpainlevelsandcreateadiaryofpainlevel;

b. Provideasetoffixedcardioexercisesandcreateanexercisediaryofcompleted

exercises;

c. Providepainrelievingpositions;

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d. DownloadaninformationpamphletaboutCR;

e. Video-podcastaboutthecondition;and

f. Thecustomfront-endalsohadaudiooptionsothepatientcouldlistentothe

informationintheapp.

2)ThecommercialExorLiveexerciseplatformwasadded.Thisplatformprovidedtheabilityfor

thecliniciantotailortheexerciseprogramtothepatientandtheabilitytochangeorassignnew

setsofexercisestopatientsovertime.Theplatformalsoincludesinstructionalvideosofhowto

doeachexercise.TheExorLiveplatformdidnotofferaudiooutputtoinstructionalvideosor

instructionslikethecustomizedfront-endoftheapp.

Thesystemswereserver-basedandaccessedusingapersonalaccount.Theclinicianwasableto

viewthepainandexercisediaries(Figure6).

Onthefinalmeetingbetweenthedevelopersandpartners,itwasdecidedthatthe4thversion

wouldbetheprototypethatwouldgotoalargerscaleproof-of-conceptbecauseitmettheneeds

ofthecliniciansandpatients.Afeasibilitystudywouldbeconductedtoevaluatetheprototype.

Side24af55


Figure5.RehAppversion4RehAppandExorLiveplatform

Side25af55


Proofofconcept

TestofthefinalprototypeofRehAppinafeasibilitystudy

Backgroundandaimsofthefeasibilitystudy

BasedontheknowledgeaboutthehealthproblemandthepossiblevalueofusingICTas

describedinthebackgroundfortheoverallaimoftheproject,itwasfoundtoberelevantto

developandtesttheICTinterventioninasecondaryhealthcaresetting,wherethereisanon-

goingneedfordevelopingnewwaysofmanaginghealthcareforpatientswithspinalpaininasafe

andeffectiveway,becauseoflimitedresourcesandincreasingdemandsofinvolvingpatientsin

theirowncare.ThestartoftheclinicalpathwayforpatientswithCRwaschosenforthe

developmentandtest,becausepatientswithCRreferredtotheSpineCentreareassedinorderto

determineiftheyneedasurgicalorconservativetreatmentapproach.Inthisprocess,thereis

oftenaneedformonitoringandguidingthepatientoverafewweeksinordertodetermineifthey

canimprovewithconservativetreatmentortheyneedsurgery.Thatrequiressetupof

appointmentsintheclinicforinformation,guidanceandmonitoringofthepatientandpotentially

extramanpowerintheclinicandatthesametimefortransportandpossiblytimeofffromwork

forthepatient.ItwasrelevantandsuitabletotesttheprototypeofRehAppinthispartofthe

clinicalpathwayforthepatient.

Beforecarryingoutalargerstudytestingtheeffectiveness,itisimportanttotestfeasibilityand

userfriendlinessoftheintervention,butalsotogetinformationaboutperformanceof

questionnairesandexploretestingofpotentialprimaryoutcomesinafuturetrialasdescribedby

Lancasteretal.[19].

Thespecificstudyobjectivesandthelistofquestionswithineachobjectiveareasfollows:

1. Totestfeasibilityanduser-friendlinessofRehApp

a. WhatdidthepatientsthinkaboutRehApp?

b. Whatwerethepatients’commentsandexperience?

Side26af55


2. ToanalysetherelationshipbetweenthepatientsassessmentofRehAppandtheiractual

useofRehApp

a. HowmanytimesdidthepatientsopenRehApp?

b. WastheuseofRehAppdifferentinpatientswhoscoredalowdegreeofsatisfaction

(below5inquestion1-5inRehAppquestionnaire)?

3. ToexplorethepotentialsofRehAppandExorLivestrategiestoinfluencepainlevel,pain

self-efficacyandfunction

a. HowmanytimesdidthepatientsopentheRehApp?

b. Howdidpainchangeovertimeineachpatient?

c. WhichRehApp-strategiesweremostlyused?(1.Cardioexercises,2.Walking,3.

ExorLiveindividualexercises)

4. TotestthefeasibilityandperformanceofPainself-efficacyandDASHinthispopulationat

baseline,2weeks(threeandsixmonths)

a. Whatwasthevariationinthispopulation?

b. Howdidthevariationchangeovertime?

c. Whatwerethepatients’commentsandexperience?

d. HowdidpainandRehApp-strategiesinfluencescoringofthePSEQandDASH?

5. TocomparechangescoresinthecontrolsandinterventiongroupsinPSEQandDASHat2

weeks

6. Toreportdemographic,physical,socialandpsychologicalfactorsintheinterventionand

controlgroupatbaseline,(threeandsixmonths)

7. Tomapchallengesinrecruitmentprocedures

Side27af55


Methods

Patients

TestingofRehAppwasdoneamongpatientsreferredtotheSpineCentrewithsignsofCR

betweenMay5thandJune30th2015.Thefollowinginclusioncriteriawereused:

• Self-reportedradiatingpaininanarmofintensityfourormoreonaten-pointnumerical

painratingscale[18]

• Atleastoneclinicalsignofnerverootinvolvement

• Abletounderstand,speak,andreadDanishlanguage.

• Above18yearsofage.

Patientswereexcludediftheyneededacutereferraltoasurgicaldepartment,hadserious

pathologyandco-morbidconditionsorphysicalhandicap,whichmayhinderthepatientfrom

doingtheexercises.

ProceduresattheSpineCentre

Atthefirstvisit,allpatientscompletedtheSpineDataquestionnaireelectronically.This

questionnairecollectsdemographicinformation.Inaddition,thepainself-efficacy(PSEQ)[17]

andtheSpellDASHout(DASH)[16]werecompleted.

Aphysiotherapist,physicianorchiropractorsawpatientsaspartofthestandardproceduresinthe

SpineCentre.Thecliniciansinvolvedinevaluatingthepatientsreferredwithsignsweregiven

writtenandoralinformationabouttheproject.Theyassessedifthepatientmettheinclusion

criteriaforthestudy.Ifthepatientfulfilledtheinclusioncriteria,thecliniciancontactedHRfor

furtherassessmentandpossibleparticipationinthefeasibilitystudy.

HRintroducedpatients,whoprovidedwrittenconsenttoparticipateinthestudy,totheRehApp.

TheyreceivedverbalandwritteninformationaboutRehAppandtheappwasdemonstratedand

reviewedwiththepatient.TheparticipantsusedtheRehAppathomeforthefollowingtwo

Side28af55


weeks.IftheirsymptomsworsenedortheyhadaproblemwiththeRehApp,theparticipantscould

contactthephysicaltherapistandSpineCentre.

Inthesametimeperiod11controlpatientsfulfillingthesamecriteriawereenrolled.

Measures

AllpatientscompletedtheSpineDataquestionselectronically,aswellasPSEQandDASHat

baselineandat2weeks.Afollow-upwithSpineData,PSEQandDASHquestionnairesatsix

monthswereplannedforbothgroups.InadditionallthepatientstestingRehAppcompletedthe

RehAppquestionnaireattwoweeks.

TheSpineCentrerunsthe‘SpineData’databaseinwhichpatients’self-reporteddataandclinical

informationissystematicallycollectedatthefirstvisitandaftersixand12months[20].

TheDASHOutcomeMeasureisscoredintwocomponents:thedisability/symptomsection(30

items,scored1-5)andtheoptionalhighperformanceSport/MusicorWorksection(4items,

scored1-5).Inordertoreceiveascoreinthemainsectioninthequestionnaire,atleast27ofthe

30itemsmustbecompletedforascoretobecalculatedandinthemodulesectionallfouritems

mustbecompletedforascoretobecalculated.

InthePSEQquestionnairepatientswereaskedtoratetheirperceivedabilitytoperformthe10

activitiesdespitetheirpainona7-pointnumericratingscale,wherezeroequalsnotatall

confidentandsixequalscompletelyconfident,yieldingasumscorerangingfrom0to60.Higher

scoresindicategreaterself-efficacy.

RehAppquestionnairewasdesignedintheinnovationprocessbasedoninputfromtherelevant

usersasdescribedinthe‘Concept’section.

AnoverviewofthemeasuresisshowninTable1.

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Table1.Datacollection.Listofvariablesandthetimingofdatacollection.(w=weeks,m=monthts)

Baseline 2w 6m

SpineData x

Age x

Gender x

Educationallevel x

BodyMassIndex x

Durationofpresentepisode x

Durationofsickleaveduetoneck x

Durationofsickleavenotneck x x

Fullhoursormodifieddutiesatwork* x x

Recurrentorincidentcase x

Painintensityneck x x

Painintensityarm x x

NeckDisabilityIndex x x

EuroQol5D x x

Comorbidities x

Sleep x x

Depression x

Catastrophizing x x

Fear-avoidancebeliefs x x

Repetitivework x

Physicalworkload x x

Leisuretimeactivity x x

Expectationaboutreturntowork x

Jobsatisfaction x

Expectedofrecovery x

PainSelf-efficacy(PSEQ) x x x

DisabilitiesoftheArm,ShoulderandHand(DASH)

x x x

RehAppQuestionnaire x

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RehAppintervention

TheusersofRehAppreceivedthesameinformationasthecontrolpatientsabouttheircondition

includingsignsofredflags(lossofstrengthandsensibilityinthearmorlegsor/andlossofcontrol

overbladderandbowelfunction)andhowtocontacttheSpineCentre.Theywereinformedthat

theremightbeaneedforasurgicalassessmentiftheywerenotrespondingtoconservative

treatment.TheywereassignedindividualexercisesintheExorLiveexerciseplatforminRehAppas

describeonpage23byHR.Theseindividualexerciseswerebasedontheindividualclinical

assessment,thepatient-expressedneedandtheclinicaldecisionalgorithmforindividualized

exercisetopatientswithcervicalradiculopathy(fig.3).Likewiseadvisedaboutusinggeneral

cardiovascularexercises,activitiesandpainrelievingpositionsassuggestedinRehApp.Theywere

advisedtofollowthesuggestionsinRehAppiftheirpainlevelraisedandcontacttheSpineCentre

ifnoimprovement.

Standardcare

ThecontrolpatientsfollowedtheSpineCentre’sstandardprotocolforpatientswithCR,where

theremightbeaneedforasurgicalapproachiftheyarenotrespondingtoconservative

treatment.Theywouldthereforebemonitoredforashorterperiodtypicalnotmorethan2

weeks,wheretheywouldreceivesimilarinformationandguidanceastheinterventiongroup,but

byclinicalappointmentsandphonecalls.

Managementandguidanceinuseofpainmedicationwerethesameinbothgroups,whereboth

groupswereseenandfollowedbyanurseifneeded

Dataanalyses

1. Reportedscoresandanswersonfeasibilityanduser-friendlinessofRehAppanICTassisted

interventionwerepresentedasproportions.Commentsandpatients’experienceswere

organizedandpresentedinthemeswithquotesfromtheparticipants.

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2. AfterexaminingtheregistereddatainRehAppitwasfoundthattherewerenoclosingof

theindividualregistrationsandthereforeitwasnotpossibletoextractusefulandvalid

data.Analysesofthefollowingspecificobjectiveswerethereforedropped:

a. NumberoftimesRehAppwasopenedbyeachparticipantovertwoweekswas

thereforedropped.Thereforenoanalyseswereperformedonfrequencyof

RehApp-useinrelationtoscoringofRehAppintheRehApp

b. PotentialsofRehAppandExorLivestrategiestoinfluencepain

3. AnalysesoffeasibilityandperformanceofPainself-efficacyandDASHweredoneby:

a. ReportedscoresatbaselineandtwoweeksinDASHandPSEQquestionnaires

werepresentedasmeanwithstandarddeviations(SD),95%confidence

intervals(CI)andmedianswithmaximumsandminimumsintheRehAppgroup

andthecontrolgroup.

b. ChangesinmeanormedianscoresfrombaselinetotwoweeksinPSEQand

DASHweretestedusingPairedt-testwithinthe2groups.Differencesinmean

ormedianchangescoresbetweenthetwogroupsweretestedusingun-Paired

t-testbetweenthetwogroups.

c. Presentationofparticipant’scommentsandexperiencesinthemeswithquotes.

d. ScoringofPSEQandDASHinrelationtopainlevelandexercisestrategiesin

RehApp,werenotperformedduetonotusefulRehAppdataand,asearlier

described.

4. Analysesofbaselinecharacteristicsincludingdemographic,physical,socialand

psychologicalvariablesintheinterventionandcontrolgroupwerenotpossible,since

datawasnotavailableforthepresentreportingofthestudy.Itwillbeaddedatalater

time.

5. Recruitmentproceduresandchallengeswerereportedinrelationtoclinicians,patients

andclinicalsetting

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Results

1.Feasibilityanduser-friendlinessofRehApp

15outof16invitedpatients(8women)withameanageof51yearsparticipatedinthefeasibility

studyandfollowingcompletionoftheRehApp-questionnaire.

Alargeproportionofthe15patientsratedRehApppositiveinthefirst5questionsabout1)the

overallperformance,2-3)user-friendliness,4)abilitytohelpwithfeelingconfidentinhandling

theirsituationand5)relevanceofexercises,onascalefrom0-10where0wherepoorand10was

excellent.Ifclassifyingscoresabove5aspositiveinthe5questions,theproportionofpositive

responsesrangedfrom65-85%.

14outof15patientsreadtheinformationpamphletaboutCRand13ofthemfoundithelpful.

13outof15patientssawtheinformationalvideopodcastaboutCRand12foundithelpful.

PatientswereaskedmorespecificallyaboutwhatwerethepositiveaspectsofRehApp.Atotalof

13patientsanswered.ThepositiveaspectsthatweremostlystatedwerethatRehAppcouldhelp

themwith:1)theirneckproblem(54%),2)withunderstandingtheirexercisesbetter(62%)and3)

withrememberingdoingtheirexercises(70%).About1/3ofthepatientsstatedthatreduced

transportationwasapositiveandtwopatientsstateditwouldbecost-effective.

OnthequestionaboutwhatcouldbeimprovedinRehApp,fourpatientsstatedtheywouldlike

beingabletocommunicatedirectlywithaclinicianthroughRehApp.Twopatientssuggestedaudio

optionsinexercisevideosintheExorLivepartofRehApp.Twopatientsfeltthattheinformation

abouttheirneckproblemandchoiceofexercisescouldbeimproved.Inaddition,following

individualsuggestionsforimprovementweregiven:

• Abilitytorecordanduploadvideosforfeedback.

• BetterinformationabouthowRehAppworked.

• Easiernavigationintheapp

• Improvementofthelogonprocedure.

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• Cardioexercisesshouldbemoreadjustableintimeandintensity

53%ofthepatientspreferredusingRehAppinsteadofvisitstotheSpineCentre,and47%ofthe

patientsfelttheywouldhaveneededmorevisitstothecliniciftheyhadnotusedRehApp.All

exceptthreepatientswouldrecommendRehAppforotherpatientswithasimilarproblem.

2.Patients’assessmentofRehAppcomparedtoregisteredinformationaboutuseofexercisesand

informationinRehApp.

TheintentionwastoexploretherelationshipbetweenhowpatientsratedRehAppandhowoften

theyaccessedandusedRehAppforexercisesandinformation.Intheanalysesofthedatain

RehAppitwasfoundthatsincetherewerenoclosing-pointtoactivitiesinRehApp,exceptforan

optionalregistration,itwasnotpossibletoperformtheanalyses.

2a.PotentialsofRehAppandExorLivestrategiestoinfluencepainlevel,painself-efficacyand

function

Asabove

3.FeasibilityandperformanceofPainself-efficacyandDASHinthispopulationatbaselineandtwo

weeks

AlltheparticipantsinthefeasibilitystudycompletedDASHatbaselineandtwoweeks.11control

patientscompleteditatbaselineandsevenattwoweeks.Inorderforascoretobecalculatedat

least27ofthe30itemsmustbecompleted.Thisexplainsthevariationinthetotalnumberof

participants.asseeninTable3.

Atbaselinemeanagewere55intheRehAppgroupsand44inthecontrolgroup,whichwas

significantlylower.12RehApppatientsand11controlpatientscompletedthedisability/symptom

sectionwithanaverageDASHscoreof37and45respectively.Theoptionalsportandwork

moduleswereansweredbynineandonepatients,respectively,intheRehAppgroupandonein

thecontrolgroupandwerethereforedroppedfromtheanalysisduetosmallnumbers(Table3).

TherewasasignificantchangeintheRehAppgroupinthedisability/symptomsectionwithalmost

Side34af55


10%decreaseindisabilityscorefrom37to27attwoweeks.Otherwisenosignificantchanges

withinthegroupswereobserved(Table2).

AllRehApppatientsand11controlpatientsalsocompletedPSEQatbaselineandat2weeks

except4controlpatients.Themeanscoreatbaselinewere34and26respectively.Withinthe

groupstherewerealmostnochangingscoresaftertwoweeks(Table2.).

4.ChangescoresinthecontrolsandinterventiongroupsinPSEQandDASHat2weeks

TherewerechangesinDASHscoresfrombaselinetotwoweeksforbothgroupsbothno

significantdifferencesbetweengroups(Table3).InthePSEQ,therewereonlysmallandno

significantdifferencesbetweenthegroups.(Table3)

IngeneraltherewereobservedfairlywideCI’slargeandSD’sinthemeanscoresforbothgroups

especiallyintheDASHQuestionnaireatbothbaselineand2weeks,indicatingalargelevelof

variancewithinthegroups.

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Table2.ChangesinDASHandPSEQfrombaselineto2weekswithinthegroups. RehApp

baseline

RehApp

2weeks

Mean

Change

P

value

Control

Baseline

Control

2weeks

Mean

Change

P

value

DASH(n)

Mean

SD

95%CI

12

37

22

(13-44)

12

27*

23

(13-42)

12

-10

12

(-17--2)

p<0.05

7

46

19

(29-63)

7

43

21

(23-63)

7

-3

5

(-8-1)

p=0.10

PSEQ(n)

Mean

SD

CI

15

34

15

(26-42)

15

35

16

(26-44)

15

1

9

(-4-5)

p=0.72

7

23

11

(12-34)

7

23

11

(13-33)

7

-.3

4

(-4-3)

p=0.86

n:Numbersofparticipantswithcompletescores;SD:standarddeviations;CI:95%confidenceintervals;*=p<0.05

5.Presentationofparticipants’commentsandexperiencesinthemeswithquotes

Inadditiontocompletingthequestionnaires,therewasalsoanoptionofaddingcommentsto

bothquestionnaires.Thereweremainlyonlyfewcomments,whichwereaboutdetailsoftheir

condition,otherhealthproblemsandtreatment.Quotefromoneofthepatients:‘Ihavestartedin

physiotherapyandhavereceivedsomeexercisestodo.I’llseeiftheyrelievemypain,whichis

increasing.IamgoingtoseeashoulderspecialistinSeptember’.

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Table3.DASHandPSEQatbaselineand2weeksinandbetweenthetwogroups.Baseline P

Value

2weeks P

Value RehApp Control RehApp Control

Age

N

Mean

(SD)

(CI)

Median

(min-max)

15

55.15

(9.90)

(49.67-60.63)

56.3

(41-78)

11

44.13*

(4.13)

(41.35-46.90)

43.8

(38-51)

P<0.01

DASH

N

Mean

(SD)

(CI)

Median

(min-max)

12

36.78

(21.91)

(22.86-50.70)

39.17

(3-75)

11

45.53

(15.59)

(35.05-56.00)

44.17

(20-70)

P=0.28

15

31.08

(23.18)

(18.24-43.92)

33.33

(2-78)

7

42.74

(21.50)

(22.85-62.62)

45

(8-71)

P=0.27

PSEQ

N

Mean

(SD)

(CI)

Median

(min-max)

15

34

(15.08)

(25.65-42.35)

32

(18-59)

11

26.18

(12.20)

(17.98-34.38)

26

(7-51)

P=.16

15

34.8

(16.44)

(25.69-43.90)

32

(8-58)

7

22.86

(11.04)

(12.65-33.06)

21

(9-41)

P=.06

n:Numbersofparticipantswithcompletescores;SD:standarddeviations;CI:confidenceintervals;*=p<0.05

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6.ScoringofPSEQandDASHinrelationtopainlevelandexercisestrategiesinRehApp

TheintentionwastoexplorePSEQandDASHscoresinrelationtopainlevelandexercise

strategiesinRehApp.Asdescribedearlier,thecollecteddatainRehAppisnotusableforthis

analysis.Itwasthereforenotpossibletoexplorethisobjectivefurtheratthispoint.

7.Demographic,physical,socialandpsychologicalfactorsintheinterventionandcontrolgroupat

baselineand6mo.

(Thispartoftheresultswillbeenteredatalatertime,whenwehavereceiveddatafromSpineData

database.)

8.Mappingofchallengesintherecruitmentprocedures

Challengesinrecruitmentprocedureswereseeninrelationto:

1. Clinicians

Therewasalargegroupofclinicianswhowereaskedtobethefirstcontactpointforthestudy.

Theywereresponsibleforinitiatingtherecruitmentprocess,butbecauseitwasnotpartoftheir

normalworkloadtheytendedtoforgettodoit.Theclinicianswerewellinformedaboutthestudy

andweremotivated.Theyreceiveddailyreminders,emailsandcasualconversations.

2. Logistics

Itwasdifficulttobuildagoodroutineininclusionproceduresintheclinicalsettingbecauseof

severalmajorlogisticalandproceduralprocesseswerebeingappliedatthesametime.Anew

guidelinefortheclinicalexaminationwasimplementedandanewmedicalITsystemwasinstalled.

Thisresultedinanincreaseintheirworkload

3. Patients

Recruitingthepatientsonthefirstdayattheclinicwaschallengingandquestionablebecausethe

patientshadalreadybeenexposedtoalargeamountofexaminationsandinformation.They

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wouldoftenexpressthattheywerenotabletoprocessmorethatday,bothduetopainand

feelingfatigued.

Discussion

Thisfeasibilitystudyinvestigatedandexploredthefeasibilityofaprototypeofaninformation-

andexercise-appcalledRehApp,inpatientswithCR.Theoverallstrengthsofthefeasibilitystudy

werethatitwascarriedoutinaclinicalsettingwiththedailyroutinesandchallenges,which

improvedthevalueoftheobservationsandresultsforfuturedevelopmentanddesignofthemain

study.Performingafeasibilitystudyalsoallowedforexploringawiderangeofobjectivesand

questionsrelatedtotheinterventionandforcollectingalargevarietyofinformativeobservations

anddata.

Theresultsshowedingeneralverypositiveresponseinrelationtobothuserfriendlinessand

relevanceoftheapp.Therewereseveralsuggestionsforimprovements.Theywereespecially

relatedtotechnicalimprovementsandtothecontentoftheapp.Oneofthefocusareaswasalso

audioandvideooptionsaswellascommunication.Nooneexpressedaneedforbeingableto

communicatewithotherpatientswithCR.Thiswasanimportantpointinthemasterthesisabout

“livedexperienceforthepatientandalsotheexperienceintheSpineCentre,whereitwasan

importantelementofthegroupexercisesessionsasexpressedbytheclinicians.Thisindicated

thattheresultsofthissurveymightnotbecoveringallaspects.Sinceitwasaquestionnairewhere

mostanswersweregivenonaratingscaleorinmarkedboxesitnarrowedthevariationand

nuancesintheanswersandimportantaspectsandissuescouldhavebeenleftout.

BeingpositivetowardsRehAppdoesnotnecessarilymeanthattheparticipantsimproved.The

explorationoftheDASHandPSEQweretoexploretheperformance,butitalsoinformedofhow

theparticipantspainefficacyandfunctionwereduringthetestperiod.Themeanscoresinboth

questionnairesdidnotindicateworseningduringthetwoweeksandinfactaslightbutsignificant

improvementintheRehAppgroupwasnoticedattwoweeks.Thisshouldbenotedwithsome

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caution,sinceitisaverysmallsamplesizewithnorandomizationorblinding.Theimprovement

mightthereforebeduetobias,suchasselectionbias,potentialinfluenceoftheinvestigator’s

positiveattitudetowardstheinterventionandparticipantswhowereeagertoplease.The

improvementinDASHscoreswasnotreflectedinthePSEQscores.Inotherwordsthepatientsdid

improvetheirfunctionallevelbutnottheirperceivedabilitytoperformactivitiesdespitetheir

pain.Thisseemedcontradictoryandmightindicateproblemswithresponsivenessandvalidityin

thequestionnairesinthispopulation,butmostlikelyitisduetothesmallsamplesize.

Thewideconfidenceintervalsandstandarddeviationsinthequestionnairesindicatedfirstofall

thatthiswasasmallsamplesizescreatinglargervariationinthegroup.Therewerethoughsimilar

variationwithinthegroupsovertimeandquestionnaireswouldberelevanttotestfurtherin

ordertomeasurevalidityandresponsiveness.

Objectives/questionsofinterestinthestudywerealsotoexplorepatients’assessmentofRehApp

comparedtoregisteredinformationaboutuseofexercisesandguidanceinRehAppaswellas

RehAppstrategiespotentialinfluenceonpainlevelandfunction.Theseobjectivesweredropped,

sincedatainRehAppwasnotusableforfurtheranalyses,partofthiswasbecauseofnoclosing

pointsintheregisteredindividualactivityandonlyveryfewpatientshadregisteredstartpointof

individualactivities,andjustlefttheappopenafteruse.Theoriginalintentionswiththese

objectivesweretogetmoreknowledgeandunderstandingofpatients’compliancewithexercises

andtheirexerciseandactivitypatternsinrelationtotheirpainanddisability.Thepositive

responsesandlow/missingregistrationofexercisesinRehAppwereinterestingandinsome

aspectstheyseemedconflicting.Thiscouldbeduetodifferentreasons;1)theexercisepartwas

notimportanttothepatientanditwasotherelementsintheappthatwashelpfulforthepatient

2)theyexercised,butdidnotregisterand/ortheprogrammingofregistrationinRehAppwasnot

sufficientlydesigned.Incaseitwasthefirstreason,itmadeonewonder,whatshouldbethe

implicationsforexploringtherelationbetweenpatients’improvementandexercisepattern.In

caseoftheotherreason,itwouldindicatethattheremightbesomechallengeswithregistration,

sincethepatientmightbedoingtheirexercises,butarenotusingtheapp.Asonethepatients

Side40af55


reported:‘AfteracoupleofdaysIcouldremembermyexercises,soIdidn’thavetoopentheapp

everytime’.Thisunderlinedtheimportanceofmakingtheresearchquestionclearandrealisticto

answer,inadvance,andensurethattheprogrammeddataregistrationintheapp.werecapableof

answeringthis.

Asbroughtupintheclinicianinterviewintheinnovationphase,theremightbeotherormore

outcomesthanpainandfunctionthatareimportant.SinceCRalsocauseseconomicburdenon

boththepatientandsocietyitwouldberelevanttohaveoutcomessuchasreturntoworkand/

orsickleave.Itwasalsomentionedthatitwasimportanttomeasureoutcomesbasedonmore

personalgoalsfortheindividualpatient.Painisontheotherhandanimportantoutcomemeasure

inthispopulation,sincetheyoftenhaveseverepainandsignsofnerverootaffection.

Thefeasibilitystudyalsorevealedchallengesintheinclusionprocedurerelatedtoinformationand

collaborationwithclinicians,logisticalconditionsaswellaspatientrelatedchallengesdueto

extensiveinformationandcommunicationwithavariousnumberofhealthcarepersonsinthe

samevisit.Thisinformsofaneedfortimelyplanningwithearlyinformationonstaff-meetings.

Smallergroupsmightbeasolutionaswell,sinceitwouldmakeiteasiertomanage,evenifit

mightincreasetheinclusionperiod.Inrelationtopatientsitmightbeimportanttosplitthe

inclusionprocessandintroductionupintwosessionsinordertodecreasetheinformation

overloadonthepatient,whoisalreadyinastress/overloadsituationduetotheircondition.

Theresultsandinformationfromthefeasibilitystudysuggestscontinuationoftheinnovative

processwithfurtheradjustmentanddevelopmentofRehApp.Inaddition,developmentofastudy

protocolbasedonresultsandsuggestionsfromthefeasibilityandinnovativeprocessforafuture

studytestingtheeffectivenessofRehApp.

Besideshavingpotentialbenefitsforthepatients,itmighthelptheclinicianindeveloping

treatmentapproachesbasedonfeedbackfromexercisehistoryinRehAppandpatients’

preferencesanddeliveringamoretailoredtreatmentapproach.Theresultsfromthisprojectmay

thereforeprovidebasisfordevelopingmoresophisticatedtechnologiesthatcanimprovedthe

Side41af55


treatmentoutcomesfornotonlypatientswithCR,butforothergroupswithmusculoskeletal

problems.

RehAppwillalsohavepotentialofdecreasingcostsnotonlyfortheindividualpatient,butalsoin

thehealthcaresystemandsocietybecauseofdecreaseinhealthcareconsultationsandsickleave.

Conclusion

ThisfeasibilitystudybasedonaninnovativeprocessshowedthatanICTassistedintervention

RehAppoverallisafeasibleandapotentialinterventionathomeforpatientswithcervical

radiculopathyinthesub-acutephase.Theresults,suggestionsandinformationachievedinthe

innovationprocessshouldbetakenintoconsiderationifandwhenproceedingtothenexttwo

phasesintheinnovationprocesswhereafinalversionofRehAppisdevelopedastheintervention

inalargercomparativestudy(fig.2).

Side42af55


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2. Sundhedsstyrelsen: Specialevejledning for neurokirurgi. Sundhedsstyrelsen 2012, j.nr. 7-203-01-90/28.

3. Thoomes EJ, Scholten-Peeters W, Koes B, Falla D, Verhagen AP: The effectiveness of conservative treatment for patients with cervical radiculopathy: a systematic review. Clin J Pain 2013, 29(12):1073-1086.

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5. Wong JJ, Cote P, Quesnele JJ, Stern PJ, Mior SA: The course and prognostic factors of symptomatic cervical disc herniation with radiculopathy: a systematic review of the literature. The spine journal : official journal of the North American Spine Society 2014, 14(8):1781-1789.

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7. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S: Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007, 334(7600):942.

8. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE: Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare 2010, 16(3):120-127.

9. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K: Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab 2009, 11(10):913-930.

10. Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP: Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J 2012, 21(8):1459-1470.

11. Rubinstein SM, van Tulder M: A best-evidence review of diagnostic procedures for neck and low-back pain. Best practice & research Clinical rheumatology 2008, 22(3):471-482.

12. Sundhedsstyrelsen: National Kliniske retningslinjer for ikke-kirurgisk behandling af rodpåvirkning i nakken udstrålende symptomer til armen (cervikal radikulopati). In.; 2015.

13. Kynde I RS, Rasmussen H, Boyle E, Nielsen LN, Sørens J: Program development of a novel information and communication technology-based care management for patients with radiating neck pain using an Intervention Mapping approach. In. University of Southern Denmark: Centre for Applied Health Services Research

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Appendix1

Interviewguide(patients)

1. Overordnethvordansynesduapp’enfungerede?

2. Vardenanvendelig/nematbruge?

3. Varvejledningogøvelsertilatforstå?

4. Dækkedevejledningogøvelsernogleafdeforventninger/behovduhar?

5. Hvadbehøverduforatkunneoverkommesådanneudfordringer?

6. Vardernogetderbekymrededigvedatbrugeapp’en?

7. Hvisdennenyetypetræningsprogramogvejledningblevtilbudt,villedusåvære

interesseretiatdeltage?

8. Trorduenappsomdennevillehjælpedigtilatfølgevejledningerogudføredineøvelser?

9. Overordnetset,hvadvilleduhavebehovfor,foratfåetpositivtudbytteafensådanapp?

10. Harduandrekommentarerellererfaringerduvildele?

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Appendix2

Interviewguidetiltestaf’Reh-app’(Kliniker)

Klinikerinformationogspørgsmålom’Reh-app’

Vieriøjeblikketigangmedatudvikleen’app’,somkaninformerepatientermednakkesmerter

ogudstrålingtilarmomhvordanmanbedstmuligtkanhåndteresinesmerterogtræneudenat

forværresmerterogsymptomer.

Ligeledesvilapp’engivebehandlerenmulighedforatkunnefølgepatienteniforholdtil

træning/aktivitetsniveausamtsmerteniveau.App’envilogsåkunnevejledeompatientskaltage

kontakttilbehandler.

’App’enerikkefærdigudvikletogindeholderikkealledeelementervitænkervilværerelevante.

Foratgøreapp’ensårelevantogbrugervenligsommulig,vilviderforgernehavedineinputtil

udviklingenafapp’en:

1. Meddinkliniskeerfaring/baggrund,erdetsåoverordnetmuligtatanvendeensådan’app’

tildennepatientgruppe?

2. Hvadskaldertilforatgøredensuccesfuld?

3. Erdernogenpotentielleudfordringer?

4. Erdernogenbetænkeligheder/problemeriathåndtere/behandlepatientermedCRmed

dennetilgang?

5. Hardu/Inogleløsningsforslagtildisseudfordringer/betænkeligheder

6. Uddybhvordananvendelsenafen’app’villepåvirkedinkliniskepraksisirygcenteret?

7. Hvadvilledin/jeresrolleværehvisensådaninterventionblevimplementeret?

8. Hvisdu/Iskulledesigneen’app’,hvadskulledenindeholdeoghvordanvilledu/I

implementere/sættedenibrug?

9. Hvaderefterdinmeningdetvigtigsteoutcome/resultatforpatientermedCRvedbrugafensådan’app’?

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Appendix3

Resultsofthepatientinterviewstheconceptphase

Overallassessment

Ingeneral,allexceptoneexpressedthattheappwasrelevantfortheirproblem.Theonethat

didn’tfinditrelevantstateditwasbecausetherewasnotenoughspecificexercisesfortheneck,-‘

itwasmorelikeawarm-uppassforasoccerteam…’Theyfoundithelpfulthatyoucoulddoyour

exerciseswhereandwhenyouwantedanditwashelpfulandthatitwasnicewithexercisesthat

consideredyourpain






• Notsomuchrelatedtotheneck.Itseemedmorelikewarm-upexercisesforsoccer

User-friendliness


• Abitofahassleinthebeginninginthebeginning

• Irritatingthatyoucouldn’tignoreanexerciseorgoback

• Easytounderstandthedirections

• Easytouse

• Ilearnedtodotheexercises,soIdidn’thavetolookintheapp

• Icouldn’tfigureouthowtousetheexerciseprogram,sodidn’tdoit

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Positives

• Itwasnicethatyoucouldalsoprintoutyourexerciseprogram

• Theapphelpedwithgainingmoreknowledgeabouttheconditionandhowtohandleit

• Ithelpedwithunderstandingexercisessinceyoucouldreadandwatchvideosandrepeatit

• Itallowedforflexibilityinwhereandwhentodoexercise

• Itsavedtimeandmoneysinceyoudidn’thavetotaketimeofffromworkandspenttime

andmoneyontransportationtheclinic

• Ithelpedmetobetterunderstandtheexercisesandtoremembertodothem

Deficiencies

• Almostallfivealsomentionedtheneedforaudiooptionintheapp,

• Optionofbeingabletogobackandforwardsorjumpoveronetheexercisesifneeded.

• Optiondrawingwherethepainwas

• Asortofexercisedairywhereyoucouldalsoseepainlevels

Suggestions

• Abilitytochatwiththeclinicianorotherpatientswouldbenice

• Optionofuploadingphotosorvideosforfeedback

• Moreinformationaboutmycondition

• Itwouldbebetterifyoucouldadjustexerciserepetitionandintensityintheapp

• Receivingremindersabouttimeforexercise

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Appendix4

Resultsfromfocusgroupinterviewwithhealthcareprofessionals

Relevance

• Youhaveappsforeverything,sowhynot.Itwouldbehelpfulforpatientsthatlivefaraway

fromthespinecentreandareworking,theywouldbeabletohandletheirsituationfrom

homeincludingdoingexercisesinsteadofspendingtimedrivingtothespinecentre

• Itgivesmoresecurityandreassuranceforthepatienttohavethisapp

• Itmayhelpwithcompliancewithexercises

• Itfitsintothenewtrendsamongespeciallyyoungpeoplewhereyouexpecthealthcareto

beaservicethatworksaroundyourschedulefitsintoyourlife

Needs/requirements

• Importantwithathoroughintroductionsothepatientknowsthecontentoftheapp

especiallyinformationabout‘redflags’

• Informationandinstructionsneedtobeshortandclear

• Importantwithasimpletechnologyandclearinformationtominimizemisunderstandings

andmisinterpretationofexercisesandguidelines

• Helpfulwithoptionofvideoofexercisesinapp.

• Optionofrecordinganduploadingofpatientvideosforfeedback

• Importantthattherearesomeeasyguidelines/rulesfortheuseoftheapp

• Helpfulwithadiarytellingexerciseandpainhistory

Challenges

• Notforallpatients,somedonothaveexperienceandskillswiththeuseofICTtechnology.

Somehaveissuesandproblemsthatcannotbehandledinanapp

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• Thepatientswhocan’taffordtreatmentmightbenefitfromthis,butatthesametimethey

areoftenavulnerablegroup,thatdon’thavecapabilityofusingtheappandmanagetheir

situation

Concerns

• Developmentofatrophywithoutnoticingontime

• Nottomanyexercisesessions,thiswillstressthepatientandtheymightquitexercises

completely

• Howaboutcommunicationanddialogwithotherpatientswhichseemtobeimportantin

thegroupexerciseprogram

• Maybethosepatientswhocan’taffordtreatmentwouldinonehandbenefitfromthis

inexpensiveapproach,butontheotherhandthymightnothavesufficientresourcesand

skillstohandletheirsituationbyanappathome

• Needforsomesortofsafetyoralarmthatwillinformthepatientandclinician

Impactonclinicalpractice

• Itwillbeadifferentwaytowork.Itwillrequirethatyoucanscheduletimeforsetupofthe

appandforansweringquestionsandrespondingtoquestionsandwithfeedbackonvideos

etc.

• Wewillbemorelikeacoach/consultantforthepatient

• Itmightmeanlongerassessmentandtreatment-coursesinthespinecentre

• Itwouldmakeiteasiertomonitorandtailorinitiatedexerciseprogramsandadvices

Themostimportantcontentsoftheapp

• Thatitcouldsummariseforthepatientwhattheyhavedoneandhowmuch

• Importantwithgoalsettingthatshouldbethebaseforchoiceofexercisesandactivities

• Useofpacingprinciplesindesigningexercise/activityprogramsforthepatient

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Mostimportantoutcomesoftheuseoftheapp

• Backtowork

• Sickdays

• Specificfunctionalgoalsforthepatient

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Appendix5

SpørgeskemaomRehApp

NAVN:____________________________________________DATO:__________________

CPR:_____________________________________________

1. Dinnuværendenakkesmerter

SletingenVærstmulige

SmerterSmerter

0 1 2 3 4 5 6 7 8 9 10

2. Dinnuværendearmsmerter

SletingenVærstmulige

SmerterSmerter

0 1 2 3 4 5 6 7 8 9 10

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1. HvaderdinoverordnedevurderingafReh-App?

DårligNogenlundeGod

0 1 2 3 4 5 6 7 8 9 10

2. HvordanvarRehAppatbruge?

MegetSværHverkenellerMegetnem

0 1 2 3 4 5 6 7 8 9 10

3. VarvejledningeniRehApptilatforstå

SletikkeDelvisIhøjgrad

0 1 2 3 4 5 6 7 8 9 10

4. HarRehAppgjortdigmeretrygvedathåndtereditnakkeproblem?


0 1 2 3 4 5 6 7 8 9 10

5. DækkedeRehAppøvelsernedinebehovfortræning?


0 1 2 3 4 5 6 7 8 9 10

6. HvadergodtvedReHApp?(sætgerneflerekrydser)

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! Kanhjælpemigmedmitnakkeproblem

! Deterbilligere

! Undgårtransport

! Kanhjælpemigtilbedreatforståøvelser

! Kanhjælpemigtilathuskeatlaveøvelser

! Andet

Beskriv:

7. HvadkunneværebedrevedRehApp?(sætgerneflerekrydser)

! AtdervarlydpåøvelsesinstruktioniExorLive,såatmankunnehøreistedetfor

atlæseinstruktionen

! Mulighedforatkommunikeremedbehandler

! Mulighedforatkommunikeremedandrederharlignendeproblem

! Mulighedforatoptagevideoaføvelseogfåfeedback

! Informationenommitnakkeproblem

! Valgaføvelser

! Andet

Beskriv:

8. Læsteduinformationspjecen?

! Ja

! Nej

9. Hvisja,vardennyttig?

! Ja

! Nej

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10. Såduinformations-videoen?

! Ja

! Nej

11. Hvisja,vardennyttig?

! Ja

! Nej

12. ForetrækkerduatkommetilkonsultationveddinbehandleriRygcenteretfremforat

brugeRehApp?

! Ja

! Nej

! Vedikke

13. Villeduhavehaftbehovforflerefysiskebesøgirygcenteret,hvisduikkehavdehaft

RehApp?

! Ja

! Nej

! Vedikke

14. VilduanbefaleRehApptilandremednakkesmerterogudstrålingtilarm?

! Ja

! Nej

! Vedikke

Andrekommentarer:

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Appendix6

Summaryofsuggestionsandrecommendations

RehApp

• ImprovementofloginproceduresinRehApp

• ImprovednavigationinRehApp,includinggoingbackandforwardbetweenexercises.

Skippingexercises

• Increasedflexibilityofthecardioexerciseswithoptionofadjustingtimeandintensitylevel

• Audiooptioninindividualexercises

• Oploadingofvideo/photoforclinicianandpatientfeedback

• Communicationfunctionintheappbetweenclinicianandpatient

• Improvementofexerciseandpainhistory.Considertheuseofsymbols

• Minimaltextmoreillustrationandsymbols

• Improvement/refinementofdataregistrationinRehApp

• Formulationofresearchquestionsbasedoncurrentinformationfromfeasibilitystudy

Otherrelatedtofuturestudy

• Furthertestsofquestionnaires(DASH,PSEQ)

• Considermoreorotheroutcomes(sickleave,backtowork,patientspecificoutcomes)

• Adjustmentofinclusionprocedures

o Smallergroupofclinicians

o Earlyinformation

o MoretimeforintroducingpatientstoRehApp

Documents

Syddansk Universitet Development of RehApp - an