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4/17/2015 BMCPublicHealth|Fulltext|Theeffectivenessoftextmessagessupportfordiabetesselfmanagement:protocoloftheTEXT4DSMstudyinthedemocraticRepublicofCongo,CambodiaandthePhilippines

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Studyprotocol

Theeffectivenessoftextmessagessupportfordiabetesselfmanagement:protocoloftheTEXT4DSMstudyinthedemocraticRepublicofCongo,CambodiaandthePhilippinesJosefienvanOlmen12*,GraceMarieKu13,MauritsvanPelt4,JeanClovisKalobu5,HeangHen4,ChristianDarras6,KristienVanAcker7,BalthazarVillaraza3,FrancoisSchellevis8 andGuyKegels1

BMCPublicHealth2013,13:423 doi:10.1186/1471245813423

Theelectronicversionofthisarticleisthecompleteoneandcanbefoundonlineat:http://www.biomedcentral.com/14712458/13/423

Received: 21February2013Accepted: 19March2013Published: 1May2013

2013vanOlmenetal.licenseeBioMedCentralLtd.

ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.

Correspondingauthor:JosefienvanOlmen

DepartmentofPublicHealth,InstituteofTropicalMedicine,Brussels,Antwerp,Belgium

DepartmentofGeneralPractice&ElderlyCareMedicine,EMGOInstituteforHealthandCareResearch,VUUniversityMedicalCenter,Amsterdam,Thenetherlands

VeteransMemorialMedicalCenter,Quezon,Philippines

MoPoTsyo,PhnomPenh,Cambodia

Memisa,Kinshasa,DRCongo

Memisa,Brussels,Belgium

Diabetologist,workingatAlgemeenziekenhuisHeiligeFamilie,Reet&CentredeSantdesFagnes,Chimay,Belgium

NIVEL(NetherlandsInstituteforHealthServicesResearch),Utrecht,Netherlands&DepartmentofGeneralPracticeandElderlyCareMedicine/EMGOInstituteforHealthandCareResearchVUUniversityMedicalCenter,Amsterdam,TheNetherlands

Forallauthoremails,pleaselogon.

* [email protected]

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Abstract

BackgroundPeoplewithdiabetesfinditdifficulttosustainadequateselfmanagementbehaviour.SelfManagementSupportstrategies,includingtheuseofmobiletechnology,haveshownpotentialbenefit.Thisstudyevaluatestheeffectivenessofamobilephonesupportinterventionontopofanexistingstrategyinthreecountries,DRCongo,CambodiaandthePhilippinestoimprovehealthoutcomes,accesstocareandenablementofpeoplewithdiabetes,with480peoplewithdiabetesineachcountrywhoarerandomisedtoeitherstandardsupportortotheintervention.

Design/methodsThestudyconsistsofthreesubstudieswithasimilardesigninthreecountriestobeindependentlyimplementedandanalysed.ThedesignisatwoarmRandomisedControlledTrial,inwhichatotalof480adultswithdiabetesparticipatinginanexistingDSMEprogrammewillberandomlyallocatedtoeitherusualcareintheexistingprogrammeortousualcareplusamobilephoneselfmanagementsupportintervention.Participantsinbotharmscompleteassessmentsatbaseline,oneyearandtwoyearsafterinclusion.

Glycosylatedhaemoglobinbloodpressure,height,weight,waistcircumferencewillbemeasured.Individualinterviewswillbeconductedtodeterminethepatientsassessmentofchronicillnesscare,degreeofselfenablement,andaccesstocarebeforeimplementationoftheintervention,atintermediatemomentsandattheendofthestudy.

Analysesofquantitativedataincludingassessmentofdifferencesinchangesinoutcomesbetweentheinterventionandusualcaregroupwillbedone.Aprobabilityof



servicesandvisits.Mobiletechnologycanbeparticularlybeneficialforthemanagementofachronicdiseaselikediabetes,forinstancebysupportingbehaviouralchangeandremindersfortakingmedicationandforappointmentswithcareproviders[911].Overall,theevidenceonthefeasibilityandadvantagesoftheuseofmobiletechnologyispositive,butmanystudiesaresmallandevidenceonitseffectivenessisnotveryrobust[1216].Despiteagrowingnumberofstudiesaboutmobilephoneapplicationsinlowincomecountries[17,18],weareawareofonlyonepublicationaboutafeasibilitystudyassessingtheuseofmobilephonesfordiabetessupportinsuchcontext.Thisstudyshowedthefeasibilityofmobilephoneuseforpeersupportandhealthmessaging.Theparticipantsreportedpositiveeffectsoftheintervention,forinstanceincreasedsocialsupportcoping,yettheirphysicalparametersdidnotimproveinthe6monthsfollowup[19].Theliteratureontheuseofmobiletechnologyforsupportingselfmanagementalsopointsouttheneedformoreprocessevaluationinordertobetterunderstandunderwhichconditionsandwhysuchinterventionswork.

Thisstudywilladdressthesegaps,byevaluatingtheeffectivenessofamobilephoneDSMSinterventionontopofanexistingDSMEstrategyinDRCongo,CambodiaandthePhilippines,usingarandomisedcontrolleddesignwithafollowupof24months.Theprojectaimstoevaluatenotonlytheeffectivenessoftheinterventionineachcountry,butalsotoassesstheprocessesandcontextualfactorsthatinfluencetheimplementationofmobilephonetechnologyforsupportingselfmanagementinordertounderstandhowitworks,forwhom,underwhichcircumstances.

Methods

ObjectivesTheprimaryaimofthisstudyistoevaluatetheeffectivenessofamobilephoneDSMSinterventioninadditiontoanexistingDSMEstrategyinthreecountries,DemocraticRepublicofCongo(DRC),CambodiaandthePhilippines,toimprovehealthoutcomes(HemoglobinA1C(HbA1C)level,bloodpressure,BodyMassIndex(BMI),waistcircumferenceanddiabeticfootproblems),accesstocare(failuretoattendrate,perceivedqualityofcareandhealthcareexpenditure)andenablement(knowledge,selfmanagementandfeelingofcoping)ofpeoplewithdiabetesparticipatinginadiabetesselfmanagementeducationprogramme.Thesecondaryaimistoidentifybarriersandfacilitatingfactors,includingadditionalcostviaanincrementalcosteffectivenessanalysis,fortheimplementationofmobilephonetechnologyforsupportingselfmanagementinlowtomiddleincomecountries.

StudydesignThestudyconsistsofthreesubstudieswithasimilardesigninthreelowtomiddleincomecountries,whichwillbeindependentlyimplementedandanalysed.ThedesignisatwoarmRandomisedControlledTrial(RCT),inwhichatotalof480adultswithdiabetes(type2or1)participatinginanexistingDSMEprogrammeineachcountry,willberandomlyallocatedtoeitherselfmanagementeducationasprovidedbytheexistingprogramme(usualcare)ortoselfmanagementeducationplusamobilephoneselfmanagementsupportintervention.Participantsinbotharmscompleteassessmentsatbaseline,oneyearandtwoyearsafterinclusion.

EthicalapprovalMedicalethicalapprovalforthisstudywasobtainedfromtheInstitutionalReviewBoardoftheInstituteofTropicalMedicineAntwerp(11245776),theMedicalEthicsCommitteeoftheUniversitairZiekenhuisAntwerpen(B300201111924),theNationalEthicsCommitteeforHealthResearchinCambodia(207NECHR),theUniversityofKinshasaintheDemocraticRepublicofCongo(ESP/CE/050/11)andtheVeteransMemorialMedicalCentreinthePhilippines(VMMC2011012).

StudycontextandpopulationThetargetpopulationconsistsofpersonswithdiabeteswhoarepresentlyparticipatinginexistingDSMEprogrammesintheDRC,CambodiaandthePhilippines.TheoverallprevalenceofdiabetesinDRCisestimatedbetween3.2%,inCambodiaat2.9%andinthePhilippinesat10.0%(IDF[20,21]).TheseexistingDSMEprogrammeshavebeendevelopedinreactiontotheirsurroundinghealthsystemanditswidersocial,culturalandeconomiccontext[22,23].Tosomeextent,thethreeDSMEprogrammescouldbeexplainedasexemplaryfortheircontext.

InDRC,thestudycontextisanestablishednetworkof60primarycarefirstlinecentresfordiabetescareinKinshasa,inwhichspecialisednurses,referredtoas



Figure1.Context,studysitesandblockrandomisationoftheTEXTFORDSMstudy.

educators,acttoimplementtheDSMEprogramme.Fivecentreshavebeenpurposivelyselectedtorecruitstudyparticipants.SimilartoothercountriesinSubSaharanAfrica,professionalcareforpeoplewithdiabetesisusuallyprovidedathealthservices[24,25].TheDSMEprogrammeinthePhilippinesisprovidedbyanumberofspeciallytrainedBarangayorcommunityhealthworkersand/ornursingaides/midwivesaseducatorsinQuezonCity(MetroManila),intheCityofBatac(IlocosNorteProvince)andinthemunicipalityofPagudpud(IlocosNorteProvince).HealthsystemsinAsiancountrieshavealongstandingtraditionofsuchcommunityhealthworkersinthedeliveryofprimarycare.TheDSMEprogrammeinCambodiaisfacilitatedthroughcommunitybasedpeereducatornetworks,whichbeganin2005asarelativelynewdevelopment.PeereducatorsareresponsiblefortheDSMEprogrammeforpatientswholiveintheirarea,supportedbyaheadquarterofficeinPhnomPenh.Ninepeereducatorshavebeenpurposivelyselectedfromoneurbannetworkand6ruralnetworksin2provinces(KampongSpeuprovince,Takeoprovince).

BecauseofdifferencesintheexistingDSMEprogrammesineachcountry,thenumbersofdiabeticscaredforbyoneeducatoraredifferentinDRCongo,CambodiaandthePhilippines.Thepurposiveselectionofparticipatingcentresineachcountryisbaseduponcomparablepatientsize,qualityofDSMEprogramme,willingnessofDSMEprogrammestafftobepartofaresearchprojectandconveniencefactorssuchastraveldistance.Figure1showshowthedesignisimplementedineachcountry.

SamplesizecalculationTheprimaryoutcomemeasureonwhichthesamplesizecalculationisbasedisthedifferenceintheproportionofdiabeticswithawellcontrolledHbA1C(definedasHbA1C



theirexistingDSMEprogrammeuptothelevelofaminimumpackage.Thiscomprisesacoherentstoryexplainingdiabetesforpatientsandkeymessagesaboutninespecificdimensionsofdiseasemanagement:1)explanationofdiabetes2)healthyeating3)physicalactivity4)monitoring5)medications6)footcare7)tobaccoandalcoholcontrol8)patientheldrecordsand9)problemsolvingbyandempowermentofpatients[31,32].TheminimumpackagehasbeendefinedthroughaconsultationprocesswithpeoplefromtheexistingDSMEprojectsandwithdiabetologistsprovidingexpertadvice.Theminimumpackageislocallyvalidatedandfinetunedtothelocalcontextbyeachcountryteam,incollaborationwithlocalprojectstaff,healthcareprovidersandpatients.TherewillbeawrittencurriculumoftheDSMEprogrammeineachcountry.

InterventionThecontentandprocessofDSMSisbasedupontheminimumDSMEpackageandonelementsofbehaviourtheory,aimingtoinfluencethemodifyingfactorsofbehaviour.DSMSmessagescan,forinstance,increaseknowledgeaboutcertainbehavioursandtheireffects,theycancreatenormativebeliefsandsocialpressureandtheycanprovideemotionalsupportandincreasetheperceptionofcontrolbypeoplewithdiabetes.MessagesforDSMSwillfollowtheninedimensionsofDSME,butwillbelocallydevelopedandvalidatedthroughconsultationswithDSMEstaffandpeoplewithdiabetes.Thelocalvalidationpertainstothelocalmeaningofhealthbehaviours(forinstancewhatisahealthydiet)butalsotolocallyrelevantmodifyingfactorsofbehaviour(constraintsfordoingphysicalexercise).Theparticipantsallocatedtotheinterventiongroupwillreceivearegularmobilephone.TheywillreceivestandardisedandindividualisedProjectInitiatedCommunication(ProjIC)throughShortMessagingServices(SMS),whichimpliesthemaximumlengthofmessagesbeing160characters.ThesoftwareFrontLineisusedtosendSMSinanconvenientway.Furthermore,peopleareencouragedtousethephonetocontactotherpeopleincludingfellowpatients,educatorsandproviderstoaskforadviceorprovideinformationwhenneeded,forinstancewhentheycannotcometoanappointment.Dependingonthearrangementswiththenationaltelephoneproviders,participantswillbeprovidedwithabudgetforcallsandmessages.ThisistermedPatientInitiatedCommunication(PatIC).

Tocontrolforthepotentialeffectofprovidingparticipantswitharegularmobilephone,theparticipantsallocatedtotheusualcaregroupwillalsoreceiveamobilephonebutwillnotreceiveProjIC.TheywillhowevercontinuetoreceiveassistancefromtheireducatorsaccordingtotheDSMEprogramme.

TheeducatorsarenotinvolvedintheinitiationofDSMSrelatedcommunication.However,alleducatorswillbeprovidedwitharegularmobilephonesothattheycanbereachedbypatients.Theywillreceiveamodestmonthlyallowancetocompensatethemfortheadditionalworkandcoststhattheywillhavebecauseoftheintervention:receivingmorecalls/SMSfrompatientstakingnecessaryactionupontheseandbeinginvolvedinthedatacollectionforphysicalexaminationandbloodsampling.TheywillcontinuetoprovideDSMEtotheirpatientsirrespectiveoftheirallocationtooneofthetrialarms.

ThestudyprojectmanagerineachcountryisthecentralpersoninprovidingProjICtothepeopleintheDSME+DSMSgroup.He/shewillbeprovidedwithasmartphonewithinstructionsandtrainingonhowtouseit.He/shewillenterpatientrelateddataintoadatabasethatisdevelopedandmanagedatnationallevelandsendoutProjICtopatientsthatbelongtotheDSME+DSMSgroupinthedifferentparticipatingcentres/fieldsites.Hewillsupportandgivefeedbacktoeducatorswhennecessaryandcoordinateresearchdatacollectionatsitelevel.

DatacollectionFromeachparticipant,wewillcollectdatalinkedtoeachoftheresearchquestionsandobjectives.ThevariablesarelistedinTable1includingtheinstrumentsusedandthewaystocollectthesedata.Thesevariableswillbecollectedforallparticipantsatbaseline,oneyearandtwoyearsafterinclusionbytrainedresearchstaffwhowillinterviewparticipantsguidedbywrittenquestionnaires,andwhowillperformphysicalexaminationandcollectbloodsamples.

Table1.Listofvariables,measuringinstrumentsanddatasources

Thepatientquestionnaire(Additionalfile1)includesseveralscalesthatmeasuredimensionsofchroniccare:theneeds&servicesscale,attitudescaleandcontrolscalewhichareallsubscalesfromtheDiabetesCareProfile(DCP)[34]thepatientenablementscore[35]andthePatientAssessmentofChronicIllnessCare(PACICScore)[39].Thesescaleshavebeenvalidatedinheterogeneouspopulationsinclinicalandcommunitysettingsinwesterncountries[34,33].Thepatientenablementscorehasbeenvalidatedinalowincomecountry[40].Thequestionnairewasdevelopedforastudyinvolvingpersonswithdiabetesinthe



Philippines.Resultsofthatstudyareyettobepublished.Thequestionnaireswillbetranslatedintolocallanguagesandpretestedinallcountries.Wewillalsocollectthefollowingpersonalanddiabetes(care)relatedvariables:age,sex,education,diabeteshistory(yearofdiagnosis,hospitaladmissions,treatment,hypertension)andphysicalaccesstocare(distancetocareproviders).Fortheprocessanalysis,wewillassessthenumberofSMSsenttoeachparticipantintheinterventiongroupandthenumberofphonecalls/SMSthatparticipantsofbothgroupsmadetotheeducator.

Additionalfile1.Webannex1.PatientQuestionnaire.Format:DOCSize:443KBDownloadfileThisfilecanbeviewedwith:MicrosoftWordViewer

Foreachcountry,wecollectanumberofcontextualcharacteristicsfromprimaryandsecondarysources.Theseare:prevalenceofdiabetes,mobilephonepenetration,literacyrate,detailsabouttheexistingDSMEprogramme(numberofpatientspereducator,componentsofDSMEstrategies,frequencyofcontactbetweenpatientsandeducator,etc.),presenceofpatientorganisationsandknowledgeandprofessionalhabitsofdiabetescareproviders(throughselfadministeredquestionnairesenttodiabetescareprovidersintheenvironment).

DatawillbeelectronicallyenteredandcleanedthroughEpiInfo,usingadoubleentryprocedure.

DataanalysesAnalysesofquantitativedataincludingassessmentofdifferencesinchangesinprimaryandsecondaryoutcomesbetweentheinterventionandusualcaregroupwillbedonemakinguseofStataversion11.Aprobabilityof



MulticountryanalysisAftertheanalysisoftheeffectivenessoftheinterventionineachcountry,wewillperformamulticountryanalysis.Wewillanalyseifanystatisticallysignificantdifferencesintheprimaryandsecondaryendpointscanbedetectedbetweenthethreecountries.Wewillusearealisticapproachtolookforfactorsexplaininganyidentifieddifferencesbetweencountries,explaininghowtheactualinterventionledtotheobservedresultsandwhytheresultsdiffer(ornot)betweencountries[4143].Projectdocuments,projectreportsfromthefieldsitesandobservationreportswillbecollected.Indepthinterviewswillbecarriedoutwithprojectmanagersanddiabeteseducatorsandfocusgroupdiscussionswithpatientsfrombothgroupswillbecarriedout.Triangulationofdatawillbedonebycomparingtheresultsfromthesesources.TheinterviewrecordingswillbetranscribedverbatimandenteredinNVivo.Qualitativedataanalysiswillbecarriedoutusingtheprogrammetheoryastheanalyticalframework[44,45].

CosteffectivenessanalysisInaddition,wewillconductanincrementalcosteffectivenessanalysis(CEA)comparingtheDSMSstrategyinadditiontotheexistingDSMEstrategywiththeDSMEstrategyonly.Theevaluationwilltakethesocietalviewpointtakingintoaccountbothpatientandprogrammecosts.Costsincurredbypatientsconsistofdirectmedical(e.g.costforconsultation,medicationandthecostforurgentcareandhospitalisation),directnonmedical(costforusingmobilephoneforPatIC,travelcost,foodcost,costrelatedtoexercise)andindirectcosts.Indirectcostsincludethevalueoftimespentbyparticipantsvisitingeducatorsandotherhealthcareprovidersandthelossofproductivityduetoillness.Programmecostsincludethecostfordevelopmentandmanagementoftheinterventionandthecostfortelecommunication.Informationaboutpatientdirectandindirectcostswillbecollectedbyatrainedfieldresearcherwithapatientquestionnaire(seesectionondatacollection).ThevalueoftimelosseswillbeestimatedfromsecondarysourcestakingtheGDPofthethreecountriesintoaccount.Theinformationonprogrammecostswillbecollectedprospectivelybykeepingadetailedaccountofallexpendituresattheprogrammelevel.ProgrammeeffectivenesswillbeexpressedintermsofthepercentageincreaseofpeoplewithdiabeteswithacontrolledHbA1Clevel[46,47].

Discussion

ThecentralhypothesisthatwillbetestedinthisstudyisthatamobilephoneDSMSinterventionontopofanexistingDSMEprogrammewillimproveclinicaloutcomesforpeoplewithdiabetes,measuredbytheirHbA1Clevel.Thewiderangeofsecondaryvariableswillyieldinformationonintermediaryoutcomesandonotheroutcomeswhicharealsoveryrelevantfortheorganisationofsupport.

Althoughtheinterventionitselfisrelativelysimple,itseffectsarerealisedthroughcomplexprocesses,likethebehaviour(change)ofpeoplewithdiabetes.Theeffectoftheinterventionwillpartlydependonfactorsrelatedtotheprocessitself(forinstance,thelevelofinteractionandpersonalisationofmessages),butalsoontheprofileofpeoplewithdiabetes(forinstancetheirattitudetowardstheirdiabetesandtheirfamiliaritywithmobilephones)andonthecontext[48,49].

Themulticountryanalysiswillaimtounderstandanydifferencesintheeffectsoftheinterventionandtheroleofthecontext,forinstancethedesignoftheexistingDSMEprogramme,knowledgeandprofessionalhabitsofdiabetescareproviders.

Themajorlimitationofourdesignwithindividualrandomisationatthelevelofthepatientisthatwithineachparticipatingcentre,therewillbepatientsintheDSMEonlygroupandintheDSME+DSMSgroup.PatientscanbeincontactwitheachotherandthismightcausesomecontaminationbetweenDSMEonlyandDSME+DSMSpatients,resultinginasubestimationofeffect.TheindividualtargetingofthemessagesandthecentralmanagementoftheDSMSinterventionwithoutinterferenceoftheeducatorsshouldminimisethiscontamination.Anothermethodologicalweaknessisthelackoflocalvalidationofthescaleswithinthequestionnaire,whichfellbeyondthescopeofourstudy.Pretestingandlocalfinetuningwillpartlyaddressthisissue.Sincewewillusethesamequestionnaire3timesalongthecourseofthestudy,weexpectthatfamiliaritywiththeinstrumentswillgrowovertime.

Thegrowingnumbersofpatientswithchroniclifelongconditions,suchasdiabetesandhypertension,putsanimmenseburdenonhealthsystemsandpopulations[50].Scarcityofresourcesandthelackofqualityandcontinuityofhealthcareresulttohighexpenditureandverypoorhealthoutcomes.Theinterventiontestedaddressestheproblemthatthegreaterpartofdiabetesmanagementtakesplacewithoutexternalsupportandthatmanychallenges,unforeseenproblemsand



1. FunnellM:Peerbasedbehaviouralstrategiestoimprovechronicdiseaseselfmanagementandclinicaloutcomes:evidence,logistics,evaluationconsiderationsandneedsforfutureresearch.Familypractice,27Suppl2010,1(June2009):i17i22.PublisherFullText

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questionsmostofthetimeoccurattheinbetweenmomentsofthescheduledcontactswiththesupportsystem,likehealthcareprovidersandeducators.Theprojectexploitstheavailabilityofwidelyaccessibleequipmentandcommunicationtechnologytonarrowthegapbetweenthesupportsystemandpeoplewithdiabetes.Inthisway,itaddressestheneedofpeoplewithdiabetestocombinetheirlifelongconditionwiththeirotherneedsandrolesinlifeandtocontributetotheirempowerment[51,52].ItwillbeinterestingtoevaluatetheimpactofthiscomplementaryDSMSstrategyontheworkloadoftheeducatorsandhealthprovides,animportantissueforfurtherscalingupingeneralservices(WHO[53]).Thestudyaddressesgapsinknowledgeandexperienceonutilizationofmobilephonetechnologytosupportpeoplewithdiabetesindevelopingcountries.Resultswillprovideinformationtodecisionmakersregardingconditionsofimplementationindevelopingcountriesandpossibleexpectedresults.

Abbreviations

DSMS:DiabetesselfmanagementsupportDSME:Diabetesselfmanagementeducation

Competinginterests

KristienVanAckerhasafunctionintheDiabetesFootProgrammeofIDF.

Noneoftheauthorshasanyfinancialcompetinginterest.

Authorscontributions

JVOiscoordinatinginvestigatorofthestudyanddraftedthefirstversionofthistext.JVO,GMK,MVP,JCK,HH,CD,BV,GKhavebeenallinvolvedinthedesignoftheproject,thewritingoftheprotocolanditsimplementation.GMKdesignedthepatientquestionnaire.FSandKVAhaveprovidedspecialistadviceaboutdiabetesandmethodology.Allauthorshavecontributedtothemanuscriptbyprovidingcontentrelatedfeedbackandimprovementsondraftversions.Allauthorsreadandapprovedthefinalmanuscript.

Acknowledgements

ThisprojectissupportedbyaBRIDGESGrantfromtheInternatiDiabetesFederation.BRIDGES,anInternationalDiabetesFederationproject,issupportedbyaneducationalgrantfromLillyDiabetes.

WearegratefulforthesupportofLimbanazoKapinduladuringthepreparationofthesoftwarefortheintervention.WethankWimVanDamme,BartCriel,ChristianaNoestlingerfortheirsupporttotheconceptualdevelopmentofthestudy.WethankDominiqueDubourg,VeerleVanLerbergheandJorisMentenfortheirsupporttothedataanalysisplanofthisprotocolandpaper.

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