Target Group Definition - CAREGIVERSPRO-MMD · d4.4 target group definition caregiverspro-mmd page...

D4.4TargetGroupDefinition

CAREGIVERSPRO-MMD

“ThisprojecthasreceivedfundingfromtheEuropeanUnion’sHorizon2020researchandinnovationprogrammeundergrantagreementNo690211”

DeliverableNumber:D4.4,Version1.1

TargetGroupDefinition

Ref. Ares(2016)4900147 - 31/08/2016


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ProjectNumber 690211 Acronym CAREGIVERSPRO-MMD

Fulltitle Self-management interventions and mutual assistance community services,helping patients with dementia and caregivers connect with others forevaluation,supportandinspirationtoimprovethecareexperience

Projectcoordinator UniversitatPolitècnicadeCatalunya-BarcelonaTechProf.UlisesCortés,[email protected]

ProjectURL http://www.caregiversprommd-project.eu

Deliverable Number D4.4 Title TargetGroupDefinition-firstversion

Workpackage Number WP7 Title PilotPreparation

Dateofdelivery Contractual Actual

Nature ReportþDemonstratorpOtherp

DisseminationLevel PublicpConsortiump

Keywords

Authors(Partner) DrIsabelleLandrin-Dutot(CHURouen),FrédéricTétard(MDA),

ResponsibleAuthor1 DrIsabelleLandrin-Dutot Email [email protected]

Partner CHU Phone +33232886552

ResponsibleAuthor1 FrédéricTétard Email [email protected]

Partner


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Executivesummary:CAREGIVERSPRO-MMDisatoolintegratingabroaderdiagnosticapproach,incorporatingthe“live-in family” caregiver - people with mild cognitive impairment or mild to moderatedementia”dyadandconsideringthisdyadastheunitofcare.

Thisdocumentdescribes the target groups for thepilot study:wewill pilot theoptimisedapplication with 600 dyads to evaluate the clinical and social benefits for PLWD andcaregivers,aswellasfinancialbenefitsforthehealthcaresystem.

This deliverable will also elaborate the strategy of identification/definition of the targetgroups, the channel tomapandengage them, the scenariodefinitionup to the customerprofiling.

ListofAcronyms

Acronym Title

C-MMD CAREGIVERSPRO-MMDplatform

GP GeneralPractitioner

PLWD People living with Mild Cognitive Impairment and with Mild to ModerateNeurocognitiveDisorders.

MCI MildCognitiveImpairment

DSM DiagnosticandStatisticalManualofMentalDisorders

ICT InformationandCommunicationTechnology

CDR ClinicalDementiaRating

MMSE MiniMentalStateExamination


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ListofTablesTable1:C-MMDUsersdescription...........................................................................................7

Table2:FirstLevel:generalpopulation...................................................................................8

Table3:Secondlevel:Professionaldementiacarers...............................................................9

Table4:Thirdlevel:medicaldoctors.....................................................................................10

Table5:InclusionandexclusioncriteriaforPLWD................................................................10

Table6:Inclusionandexclusioncriteriaforcaregivers.........................................................11

Table7:Diagnosisprocedures...............................................................................................12

Table8:Selectionprocessforinclusion.................................................................................14

Table9:Barrierstoachieveenrolment.................................................................................15

Table10:proportionofdifferenttypesofcaregivers............................................................16

Table11:Keyfactorsforsuccessfultrialimplementationandcompletion...........................17

Table12:KeyfactorstoimproveenrolmentforPLWD.........................................................21

Table13:EngagementquestionnaireforPLWD....................................................................22

Table14:KeyfactorstoimproveenrolmentforCaregivers.................................................24

Table15:EngagementquestionnaireforCaregivers............................................................24

Table16:Retentionriskmitigationstrategies.......................................................................29


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Tableofcontent

1 INTRODUCTION 72 TARGETGROUPDEFINITION 82.1 LEVELOFSCREENINGFORTARGETGROUPS: 8

2.1.1 FIRSTLEVEL:GENERALPOPULATION 82.1.2 SECONDLEVEL:PROFESSIONALDEMENTIACARERSINTHECOMMUNITY 92.1.3 THIRDLEVEL:MEDICALDOCTORS 9

2.2 THEDYAD 102.2.1 PLWD 112.2.2 CAREGIVER 13

2.3 SELECTIONPROCESSFORINCLUSION 143 CLINICALTRIALSINDEMENTIA 153.1 BARRIERSTOACHIEVEENROLMENT 153.2 FACTORSIMPACTINGTRIALCOMPLETION 173.3 HIGHLEVELCHALLENGEMITIGATION 17

4 STRATEGYFORENROLMENT 194.1 IDENTIFYCOMMUNITIES 194.2 BENEFITSOFPARTICIPATION 194.3 RECRUITMENTTOOL 194.4 ON-LINESTRATEGYTOSUPPORTENROLMENT 20

5 STRATEGYFORENGAGEMENT 215.1 STRATEGYFORPLWD 21

5.1.1 IMPROVINGCONSENT 215.1.2 COMMUNICATION 225.1.3 ENGAGEMENT 225.1.4 BUILDCONFIDENCEANDTRUSTFORPLWDS 23

5.2 STRATEGYFORCAREGIVER 245.2.1 IMPROVINGCONSENT 245.2.2 COMMUNICATION 245.2.3 ENGAGEMENT 245.2.4 BUILDCONFIDENCEANDTRUSTFORCAREGIVERS 25

5.3 STRATEGYFORMEDICALDOCTORS 265.4 STRATEGYFORSOCIALPROFESSIONALS 27

6 STRATEGYFORRETENTION 296.1 CATEGORIZINGPARTICIPANTS 296.2 POSSIBLERISKMITIGATIONSTRATEGIES 29

7 ANNEXES 317.1 ANNEX1:DSM-IVCRITERIAAPA1994 317.2 ANNEX2:MCI-ALBERT-PETERSEN2011 317.3 ANNEX3:RESEARCHATTITUDEQUESTIONNAIRE-7ITEM 31

8 REFERENCES 33


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1 INTRODUCTIONAswithmostchronicdiseases,acollaborativepartnershipamongPLWD,caregiver (formaland/orinformal),healthprofessionals(clinicians(GPsandspecialists),nurses,psychologists,pharmacists,etc.)andsocialprofessionals(socialworkers)isneededinordertoachievethehighest quality andefficacy in assessment, treatment and support. CAREGIVERSPRO-MMD(C-MMD) platform is a new device in Information and Communication Technology (ICT)developed for the support and assistance of dyads of patients living with neurocognitivedisordersandtheircaregivers.

The C-MMD platform provides support for interactions between the following platformusers.

Table1:C-MMDUsersdescription

Users Description

PLWDPeoplelivingwithMildCognitiveImpairmentandwithMildtoModerateNeurocognitiveDisorders.

CaregiversPeople providing support and assistance to the PLWD, with or without aprofessionaland formalbackground (e.g. informalor formalcaregiver).Thosearefamilymembers,neighbours,friendsaswellaspaidassistant.

Dyad

IntheframeworkofC-MMDproject,PLWDandtheircaregiversrepresentthemainpoint of care; their interaction with the platform is also determined by therelationshipswithinthedyadandnamelytheseverityofsymptomsandconditionsofbothmembers.

HealthProfessionals

People with healthcare background,managing the health plan of the dyad; theycombineandmanagehealthdataforclinicalassessment,diagnosisandtreatmentplans;

SocialProfessionals

PeoplewithSocialbackground,managingthesocialsupportofthedyad;theydealwith the social component of the intervention, in order to improve outcomes indyad’slivesandrelationships,withspecialfocusontheirsocialstatus.

Toevaluate thebenefits of CAREGIVERSPRO-MMDplatformuse, amulticentrepilot studywillbeconductedin4countries(France,GreatBritain,ItalyandSpain)during18months.

For thispilot study, it isnecessary todefine the targetgroupsconcerned inorder tohavereliableresultsandtominimizedropoutrates.


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2 TARGETGROUPDEFINITIONThepilotstudyconsistsinevaluatingthebenefitsofCAREGIVERSPRO-MMDplatformuseforthesupportandassistanceofdyadslivingwithneurocognitivediseases.Thepilotstudywillenrol dyads involved in dementia care. In this context, the definition of target groupdescribesgroupsofpeoplewithcommoncharacteristics,andsimilarlifesituations.

Thedefinitionoftargetgroupisinfluencedbymanyfactorslistedbelow:

- ThedyadcomposedofacaregiverandPLWD- TheabilitytouseanICTdevice- Theabilitytoparticipateandcompleteapilotstudy

Therearedifferent levelsof screening. Foreach levelof screening, target groupsmustbedefined. It has been decided to define different levels depending on the way dyads arerecruited.

Theselevelsofscreeningare:

- Level1:screeninginthegeneralpopulation

- Level2:screeningbyprofessionalcaregiversofdementia incommunity(publicsectorsandvoluntaryorganizations,etc.)

- Level3:screeningbymedicaldoctors

Manyquestionsareraisedbythisstudy

- Whoselectsdyads- Wherethedyadsarerecruited(orselected):inthegeneralpopulation,memory

clinics,daycarehospital,generalpractitioners,etc.- How to select dyads involved in the project: medical screening, media,

newspapers,andInternet.

2.1 Levelofscreeningfortargetgroups:

Inordertorecruit600dyadswithinafewweeks,itisnecessarytodecidedifferentlevelsofscreening.

2.1.1 Firstlevel:generalpopulation

Thegeneralpopulationrepresentsthefirst level.Manydyads,whichfacethedisease,maywanttoparticipateinaresearchprotocol.Thisfirstlevelisagenerallevelofscreeningandamedicalevaluationisneededtodecideifthedyadshouldbeincludedinthestudy.

Table2:FirstLevel:generalpopulation

TargetGroup FirstLevel:GeneralPopulation

DyadComposed of a person living with cognitive problems, eventually with a knowndiagnosisofdementiaorMCIandacaregiver (relative, friend,professional)whoprovidesabroadrangeofassistance


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CaregiverA person who provides support and assistance and accepts to participate andcompletethestudy.He/shehasbasicknowledgeofICT

Basicknowledgeisdefinedashavingminimumknowledgeofusingacomputerorlaptoportablet:tobeabletologon,tosurftheinternet(i.e.:connectingtoasearchengineanddoabasicsearch),tosendarequestoranemail.

Oneofthesuccessesoftimelyenrolmentisawarenessofthestudy.Adyadcannotchoosetoparticipateifthisdyadisnotawareofthestudy.

Forthisfirstlevel,wesuggestdifferentwaysforrecruiting.Informationandbenefitsoftheprojectcouldbecommunicatedinthelocalpress,media(TV),advertising,Internetviasocialmedia (twitter, Facebook,etc.), voluntaryassociations (Alzheimer’sdisease, for caregivers,etc.).

Thisisthefirstlevelofscreening.Contactshouldbemadewiththeteampilotingthestudy.

2.1.2 Secondlevel:professionaldementiacarersinthecommunity

AsecondleveltoscreendyadsisrepresentedbyprofessionalswhotakecareofPLWDandtheircaregivers:publicandprivatecaresectorsandvoluntaryorganizations.

This group is represented by social workers, nurses, psychologists, professional helpers,volunteers,etc.Theycanrelayinformationontheprotocolresearch.

Forthissecondlevel,wecansuggestdifferentwaysfordissemination:specific informationdedicated to local services, localpress,advertising, Internet (email),voluntaryassociations(onAlzheimer’sdisease,forcaregivers,etc.),

Table3:Secondlevel:Professionaldementiacarers

TargetGroup Secondlevel:professionaldementiacarers

DyadPeople livingwith cognitive problems,with a known diagnosis of dementia orMCI and who have a caregiver (relative, friend, professional) who provides abroadrangeofassistance

Caregiver

People providing real support and assistance to the PLWD, with or without aprofessionalandformalbackground(e.g.informalorformalcaregiver).He/sheisin goodhealth andaccepts toparticipate and complete the study.He/shehasbasicknowledgeofICTandinternetaccess.

Afterthisscreening,personswhomeetthecriteriashouldbereferredtotheteampilotingthestudy.

2.1.3 Thirdlevel:Medicaldoctors

Medical doctors represent the third level. These professionals are general practitioners,neurologists, psychiatrists, geriatricians, etc. Some of thesemedical doctors may work inmemoryclinics,hospitalday-care,etc.


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ThesemedicaldoctorswillreceivespecificinformationontheresearchprotocolviaInternetorbypost,orinamedicalmeeting.

Ascreeningofdyads,whichare followed inmemoryclinics,hospitalday-care,etc., shouldbe done. The pilot teamwill contact thosemeeting the criteria in order to propose theirparticipationinthestudy.

Table4:Thirdlevel:medicaldoctors

TargetGroup Thirdlevel:medicaldoctors

PLWD

People living, with a known and established diagnosis of mild to moderatedementiaorMCIandwhofulfiltheinclusionandexclusioncriteriaandwhohavea caregiver (relative, friend, professional) who provides a broad range ofassistance.Thecaregivermustfulfiltheinclusionandexclusioncriteria.

Caregiver

People providing real support and assistance to the PLWD, with or without aprofessionaland formalbackground (e.g. informalor formalcaregiver).He/shefulfils the inclusion and exclusion criteria and accepts to participate andcompletethestudy.He/shehasbasicknowledgeofICTandinternetaccess.

Basicknowledgerequiredwillbedefinedashavingminimumknowledgeinusingacomputerorlaptoportablet:tobeabletologon,tosurfinternet(i.e.:connectingtoasearchengineanddoabasicsearch),tosendarequestoranemail.

2.2 TheDyad

Thedyad iscomposedofacaregiverandaPLWDwhoareclosely linkedregardingdiseasecare.Eachmemberof thedyadmustbe selectedaccording to the inclusionandexclusioncriteriadefinedinthedeliverableD4.1entitled“PilotOperationManual”.

These inclusion and exclusion criteria are listed in Table 1 for PLWD and Table 2 forCaregivers.

Table5:InclusionandexclusioncriteriaforPLWD

InclusioncriteriaforPLWD

● People,aged50andover,livinginthecommunity,whoareabletogiveinformedconsent(orthelegaltutor).

● Diagnosedwithmildcognitiveimpairment(MCI)accordingtoPetersencriteria[AlbertMSet al, 2011] (1) or mild to moderate dementia diagnosed according on DSM-IV criteria(DiagnosticandStatisticalManual,4thedition)[AmericanPsychiatricAssociation,1994](2).

● HavingaClinicalDementiaRating(CDR)of0.5forMCI,1-2formildtomoderatedementia.● Having aMini-Mental Exam score (MMSE) [Folstein et al. 1975] (3) between 30 and 25

(inclusive)forMCI,andbetween24and10(inclusive)fordementia.● Havingaprimarycaregiver,familiar(ornot),informal(ornot)identifiedandalsoincluded

inthestudy.● Willingness to use Information Technology and Communications (ICT) according to the


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investigatorcriteria.

Exclusioncriteria

Terminalorsevereillnesswithsurvivalprognosislessthan18months.Havingdelusions,hallucinations,behaviouraldisturbances,thatmayinterferewiththeuseofInformationandCommunicationsTechnology(ICT)tools.Relevant sensory problems (visual or hearing impairment) or motor disability (such asparalysis of upper limb or disabling arthritis or disabling tremor, etc.) evaluated by theinvestigator that would interfere with the use of Information and CommunicationsTechnology(ICT)tools.Notspeakingthelanguageofthecountrywherethepilotisbeingconducted.

Table6:Inclusionandexclusioncriteriaforcaregivers

InclusioncriteriaforCaregivers

People, aged 18 years and over, with no diagnosis or no evidence of mild cognitiveimpairment or mild to moderate dementia (according DSM-IV criteria) [AmericanPsychiatricAssociation,1994],whoareabletogiveinformedconsentandwithanintentiontocompletethestudy.Primary caregivers, informal (or not), familiar (or not) of person with mild cognitiveImpairmentormildtomoderatedementia.PeoplewithInternetaccessandbasicknowledgeandskillsinmanaginginternetandsocialnetworks,orkeentolearn,accordingtotheinvestigatorcriteria.Having a Geriatric Depression Scale (GDS-Yesavage - 15 items) score less than 11 at thetimeofentryintothetrialindicatingnoseveredepressivesymptoms.Havingnospecificconditions(evaluatedbytheinvestigator)reducingtheirphysicalabilitiesbelow thenorm for their age thatwould limit or impair CAREGIVERSPRO-MMDplatformuse.WillingnesstouseInformationTechnologyandCommunications(ICT)tools.

ExclusioncriteriaforCaregivers

Terminalorsevereillnesswithsurvivalprognosislessthan18months.Relevant sensory problems (visual or hearing impairment) or motor disability (such asparalysis of upper limb or disabling arthritis or disabling tremor, etc.) evaluated by theinvestigator that would interfere with the use of Information and CommunicationsTechnology(ICT)tools.Notspeakingthelanguageofthecountrywherethepilotisbeingconducted.

2.2.1 PLWD2.2.1.1 Age

ThestudyaimstorecruitPLWDaged>50years.Therewillbetwodifferentgroups.


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First,theyoungerpatientswillbemorelikelytohaveaspouseascaregiver,livingwiththem;mostofthemwillhaveaprofessionalactivity.YoungerpatientswillbemorelikelytohaveknowledgeofICTandbewillingtoparticipateinthetrial.

Thesecondgroupwillbecomposedofelderlypatients.Probably,thecaregiverswillmostlybe their children.We cannot expect to include elderly spouses in a study on ICT as theirknowledgeispoorandweshouldfocusonchildrenascaregivers.

2.2.1.2 DiagnosisproceduresOneofthekeypointsoftherecruitmentinthepilotstudyistohavePLWDwithadiagnosisof the disease. Only patients with Mild Cognitive Impairment and patients with mild tomoderatedementiawillparticipateinthestudy.Table7:Diagnosisprocedures

AdiagnosisofdementiaaccordingtoDSM-IVcriteria

A diagnosis of dementia, according to DSM-IV criteria (Diagnostic andStatistical Manual, 4th edition) [American Psychiatric Association,1994](2) should have been done according to the clinical practicebefore inclusion. This is necessary in order to eliminate differentialdiagnosisthatcouldleadtodrop-out(seeannex1).

The diagnosis must have been done by a medical doctor trained(neurologist,geriatrician,psychiatrist,etc.).

The level of severity of the disease must be determined by medicaldoctors or psychologists using CDR and MMSE done by a trainedprofessional.

ADiagnosisofmildcognitiveimpairment(MCI)accordingtoPetersencriteria

ADiagnosisofmildcognitiveimpairment(MCI)accordingtoPetersencriteria[AlbertMSetal,2011(1)](seeannex2)shouldhavebedoneaccordingtotheclinicalpracticebeforeinclusion.

Thediagnosismusthavebeendonebyamedicaldoctortrainedinthispractice(neurologist,geriatrician,psychiatrist,etc.).

Remark:Nobiomarkerstudywillbenecessaryforthisstudy.2.2.1.3 Aetiologyofdementia

Forthepilotstudy,aetiologyofdementiaisnotnecessaryasinclusioncriteria.However,inordertohavehomogeneousgroupsithasbeendecidedtoavoidincludingPLWDwithseverebehaviouraldisturbanceordelusionsorhallucinationsevaluatedbyamedicaldoctorafterquestioningthecaregiver.

2.2.1.4 ICTknowledge

NoICTknowledgeisrequiredforPLWDbutaninterestorsomeknowledgeinICTwouldbeappreciated.


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Most younger PLWD may have already used a computer, smartphone, software, andInternet.

2.2.2 Caregiver

As for the PLWD, it is important to determine the target group for caregivers. There aremanycriteria.

First,thecaregiverisdefinedasanyrelative,partnerorfriendwhohassignificantpersonalrelationshipwiththePLWD,andprovidesabroadrangeofassistance.He/shemaylivewithorseparately fromthepersonreceivingthecare.Thecaregiverwillbethemainreferenceforrecruitmentandthestudy.

The target group is peoplewhomeet the inclusion and exclusion criteria andwho acceptparticipatingandcompletingthepilotstudy.Twomaininclusioncriteriamustbetakenintoaccount:absenceofseveredepressionandabsenceofsevereillnessthatwouldlimittheuseofICT.Thiswillbedeemedbytheteampilotingthestudy.

2.2.2.1 ICTknowledge

Asthecaregiverwillbethemaincontributorontheplatform,itisnecessarythathe/shehassufficientknowledgeonICT.Onlybasicknowledgeisrequiredastheplatformisdevelopedwithsimpleandeasydesign.

Basic knowledge will be defined as having minimum knowledge in using a computer orlaptoportablet.Caregiversshouldbeableto:

§ Switch-onandswitch-offacomputer§ Loginandlogoutofaplatform§ Surf internet (i.e.: connecting to a search engine and performing a basic search

action),§ Sendarequesttoanadministratororsendanemail.

2.2.2.2 WillingnesstouseICT

Inorder toparticipate and complete the study, it is important that the caregiverdeclareshis/herwillingnesstousetheplatformandcompletethestudy.

Ahighlevelofdropouthasbeenobservedinpreviousstudiesbutthereisnoreliablescaletoevaluatethewillingnesstocompleteastudy.

TheRAQ7item-scale(ResearchAttitudeQuestionnaire)isusedtoassessthewillingnessofpatients to participate in a study. This scale is not validated for testing an ICT device indementia(4)andnocut-offisdefined.Thisscalemaybeausefultooltohelppilotteamstoselectdyadswhenadoubtispresent.

Thewillingness touse ICT and tobe activeon theplatformwill beevaluatedby thepilotteam.


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2.3 SelectionprocessforinclusionTheprocesstoselectdyadsinthestudyisdetailedintable8.

Table8:Selectionprocessforinclusion

Steps Check/Action Result

Step1First-second level: Dyad meetingcriteria and willingness toparticipatetoanICTstudy.

Contactwiththepilotteam(email,phone,etc.)

Step2 MedicalappointmentPerson with a diagnosis of MCI or mild tomoderatedementia(PLWD)confirmed

Step3

Did the patient and the caregivergive informed consent afterreceiving information on the studyanddotheyhaveICTabilities?

Dyadcompleted

Step4Evaluation of the severity of thedisease (CDR, MMSE) by medicalteamorpsychologist

The level of severity of disease is defined,inclusionandexclusioncriteriaareverified

Step5

Verification of inclusion andexclusion criteria for caregiverincluding:

§ Does the caregiver have ICTknowledge?

§ Does the caregiver have thewillingness to complete thestudy?

Inclusioninthestudyifalltheseconditionsarepresent


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3 CLINICALTRIALSINDEMENTIADifficultiesinrecruitmentforstudyinAlzheimer’sdiseasearefrequentandsomestudiesfailtoenrolintime.Thetimetoenrol600dyads(200inSpain,200inItaly,100inFrance,100inGreatBritain)isshortanditisnecessarytodefinebeforethestudywhatkindofdyadcouldbepreselectedbeforebeingenrolled.

3.1 Barrierstoachieveenrolment

Indementia, researchers facemultiple challenges inorder toachieveenrolment in clinicaltrialswhereasresearchersunderstandtheneedtodeveloptrials.Onlyonethirdof24multi-sitetrialswereabletoenrolvolunteerswithinoneyearinphaseIIorIIIstudies(5).

Thebarriersaremultiple.

Table9:Barrierstoachieveenrolment

Barriers Description

AwarenessoftrialsThosewhoarenotawareoftrialscannotparticipate.Manyindividualsaffectedbydementiadonotknowtheycanparticipateinclinicaltrialsorwheretofindinformationonstudiesintheirarea.

Physicianchallenges

Likepeoplelivingwithdementiaandtheirfamilies,lowphysicianawarenessofdementiaclinicaltrialsandotherstudiesisasignificantchallengetoenrolment.

ThediseaseDementiaischaracterizedbydifficultiesincomprehensionthatmayimpactinformedconsentprocess.Patientsmaydenytheircognitiveimpairment.

Coexistingconditions

Indementiaclinical trialsandotherstudies,Alzheimer’scancomplicatethemanagement of other comorbid health conditions and many people withAlzheimer have one or more of them. High frequency of other medicalproblems thatmaybeexclusioncriteria suchasmedications.Patientsmustbestablebeforeinclusion.

InformedconsentDifficultiestoobtaininformedconsentforpeoplewhoarenotawareoftheirdisease and risk that patient decline proposal even if a legally authorizedrepresentativeagrees.

Culturalandlinguisticdifferences

Having understood oral and written information before signing informedconsent is necessary.An evaluationof clinical practices at 36 centres in 15Europeancountriesrevealedlanguagebarriersandeducationlevelsaffectedadequate cognitive assessment and delivery of services for patients withethnicandminoritybackgrounds.

StudyThe burden due to visits and study pattern is a reason for refusal toparticipate

Previousinclusion A dyad with previous inclusion in a research study is a reason for non-


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inresearchstudy inclusion

Requirement toenroltwopeople

Fordementiastudy,aPLWDandacaregiveroraknowledgeableinformantisoftenneeded.(6)

PLWDwhodonothaveacaregiveroraknowledgeableinformantcannotparticipateinthestudy.Theroleofthecaregiverisessentialatinclusion,butalsotomonitorandforfollow-up.ThedecisionofcaregiverstoparticipateornotinthetrialisasimportantasthePLWD’sdecision.However,spousesaremorelikelytoacceptparticipatinginatrial.

Inthefourcountriesparticipatinginthepilotstudy,thepercentageofdifferenttypesofcaregiversislistedintable10.

Table10:proportionofdifferenttypesofcaregivers

Level France UK Italy Spain

Partner 44 42 25 28

Adultchildren 37 46 65 55

Other 13 12 10 17

References [AssociationFrançaisedes

Aidants,2016](7)

LocalMemoryClinicdataof

UniversityofHull

[Spadin,2007](8) [Rivera,2009](9)

[España,2008](10)

Only33%oftrialstudypartnersarenotspouses(11).Spousalcaregiversmayhavegreatermotivationthanchildrencaregiverswhoaremorelikelytobeworkingandhavelesstimetospend in a research study. The barriers for caregivers are multiple such as logistics(transportation, frequency of visits, etc.) but emotional and attitudinal factorsmay play arole(4,12).SomecaregiverscitethedoubtsofbenefitsoftheirparticipationforthePLWDasreasonforrefusingparticipation.Thefearofburnoutisoneofthereasonsofrefusal.

Otherparticipantbarriers:

§ Timeoffwork§ Transportationcosts§ Childcare§ Outof-pocketexpenses§ Notwantingtochangecurrentmedicaltreatment§ Notwantingtochangephysicians§ Mistrustofmedicalresearch


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§ Fearofstigmaassociatedwithadisorder/disease,etc.

3.2 Factorsimpactingtrialcompletion

At any time, PLWDs and caregivers canwithdraw their consent to participate in a clinicalstudyasitisstatedinregulatoryandethicalguidelines.

So, good retention begins before enrolment by recruiting participants who are likely tocomplete the study. In medication trials retention rate are about 70%. In ICT studies,dropoutrateishighandmustbetakenintoaccount.

The success of CAREGIVERSPRO-MMD pilot study hinges on ability to recruit and retaindyads.Losingsubjects isathreattothepowertodetectaplatformeffectand,potentially,thismayhaveimpactonthevalidityofthestudy.

InobservationalstudieswithPLWDapercentageofdropoutsupto55%hasbeenreportedat two years of follow-up [13,14]. In studies applying ICT in a similar way toCAREGIVERSPRO-MMD,a40%rateofPLWDdropoutshasbeenrecordedat12months[15].

Withrespecttocaregiverstudieswith interventionsbasedon internetaround28%rateofdropoutshasbeenreportedat6months[16]and33%at12months[17].

Then,afterasearchintheliterature,wewillconsidera60%rateofdropoutsinpeoplewithMild Cognitive Impairment,Mild andModerate Dementia and a 40% rate of dropouts incaregivers.

3.3 Highlevelchallengemitigation

Keyfactorsmustbetakenintoaccountforsuccessfultrialimplementationandcompletion.

Table11:Keyfactorsforsuccessfultrialimplementationandcompletion

Keyfactors Description

Clearcommunication

Informationmustbeclear,adaptedtothepersonconcerned,detailed.Asheetexplainingthetrialisgiventoeachmemberofthedyad.Aperiodofreflectionisproposed.

Informationmustdescribebenefits/risksofthestudy

Dyadsareinformedthattheywillberandomizedincontrolvsplatformgroup.Theconsequencesofthisrandomizationareexplained.

Outcomesmustbeexplained

Datacollectedareexplained


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Consistentfollowup

Thescheduleofthetrialmustbeexplainedandpilotteamshavetoverifythedyad’sabilitytoattendappointments.

Datacollectedareexplained

Predefinedrolesandresponsibilities

Theroleandresponsibilitiesofthepilotteamisexplained

Dyadsaccepttheirresponsibilitiesandtheroleofeachmemberofthedyadisexplained

Appropriateplanningandtimelinemanagement

Planningofthetrialisexplainedandappointmentsaremanagedwithdyads’wishes.


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4 Strategyforenrolment

4.1 IdentifyCommunities

Socialmarketingandcommunity-basedapproachesprovideasolidfoundationfororganizingrecruitmentactivitiesforclinicaltrialswitholderadults.Wewill identifycommunitieswithwhichwewouldliketoengageandestablishlong-termrelationshipsinordertofacilitateourC-MMDstudy.Weconsiderwecouldusequalitativefocusgroupstoassesstheneedsandpreferences of potential participants.Wewill develop plans to share the study results informatsmostusefultothedifferentcommunitiesinvolved,includingparticipants,familiesofparticipants,consumers,andreferringpractitioners.Targetedcommunitiesarethefollowingandalignedwiththesection«2TARGETGROUPDEFINITION»:

• Potentialparticipantsandtheirfamilymembers• Referringphysicians• Community-basedorganizationdirectors• Statementalhealthdirectors• Civicorganizations• Advocacyorganizations• Communitycentres• Healthclinics• Media

4.2 Benefitsofparticipation

Theconsortiumwillworkwithcommunities through focusgroups, interviews,andsurveysto develop a list of benefits (aswell as barriers) for participating in the C-MMD researchstudy. The list of benefits can be communicated to potential participants, and specificbenefitscanbeemphasizedwhenspeakingtodifferentaudiences.

When communicatingwith PLWD, C-MMD clinical teamsmight emphasize that the studyaims to improve the understanding of a disorder and improve their quality of life.Whenspeaking to family members, C-MMD clinical teams will explain that the study will notrequireaPLWDtochangehis/hercurrenttreatmentprogramandwillhelpcaregivertodealwithburn-out.

Aboutbarriersandmitigationmeasures,C-MMDteamswillcreateaFAQsheetaddressingpotentialconcernsinordertoclearupmisconceptions.

4.3 Recruitmenttool

The recruitment tool will be adapted to the target audience (potential participant vs.caregivervs.communityreferralsource)andconductpilottestsandmakesureallstaffwhocommunicateswithpotentialparticipantsreceivepropertraining.

Manyways to communicateon the studywill beused suchas: radioads,newspaperads,flyers, newsletter articles, FAQ sheets, web sites, public service announcements, pressreleases,letterstotheeditor,interviewsonTVorradio,etc.


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InformationaboutC-MMDclinicaltrialwillbeuploadedtoClinicalTrials.gov.

4.4 On-linestrategytosupportenrolment

New channels of communication will be used to give information on the project such asnetworking.

TheC-MMDteamwillbuildabrandandusevisualcommunicationmaterialstodisseminatearelevantandcoherentmessage.Acommunicationstrategybasedonaclearbrandidentitycanhelptocreateinstantrecognition,provideanassuranceofqualityacrossservices,actasa valuable platform for launching new services, and ensure the delivery of a coherentmessageacrossallmediaofcommunications.ThePilotshavesoughttocreatea‘trustandconfidence’brandthrougharangeofvisualcommunicationaids,suchastaglinesandlogos.Forexample,ashortmemorabletaglinewillhelpcatchcaregiversandPLWD’attentionandpromptthemtotakepartintheinitiative.


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5 StrategyforengagementTwostagesareimportantduringthepilotstudy:recruitmentandcompletionofthestudybythewholedyad.

Thefirststepistodevelopawarenessofthetrial.Thosewhoarenotawareoftrialscannotparticipate.

Positive PLWD, caregiver, health and social professional engagement is crucial to achievebusinessresultsandthecompletionoftrials.

5.1 StrategyforPLWD

5.1.1 Improvingconsent

For many patients, obtaining informed consent can be a barrier. In order to improveenrolment in the study, inclusion and exclusion criteria are non-restricting in this study.There is no barrier depending on disease (except for terminal illnesses), medications oraetiologyofdementia.

Oneofthedifficultiesisrepresentedbythefactthatpeoplearenotawareoftheirdiseaseor deny their disease or have comprehension impairment. The risk is that a patientmaydecline study inclusioneven if a legally authorized representativeagrees. Thenecessityofclearcommunicationanddemonstrationofthepositiveaspectsoftheirparticipationisakeypoint.

Toimproveenrolmentinstudy,PLWDaremorelikelytoparticipateif:

Table12:KeyfactorstoimproveenrolmentforPLWD


Clearcommunication

§ Theyreceiveclearinformationaboutthetrial.Thisinformationmustbeadaptedtotheleveloftheirdisease(abrochurewithquestionsandanswers-FAQ-willbegiventoPLWD),

§ ExpectedoutcomesforPLWDwillbediscussed,§ DirectindividualbenefitsoftheuseoftheCAREGIVERSPRO-MMD

platformisdiscussedwithPLWDandcaregiver.Directreturnoninvestmentisclearlyexplainedwithpatientandtheircaregivers,

§ Theyareclearlyinformedofethicalproceduresanddataprotection§ Adverseeventsarescarcecomparedtoadrugtrial.Thiswillbe

explainedtothePLWDandcaregiver.

Consistentfollowup

Thestudydesigniswellestablishedandfrequencyoffollow-upisdetailed.Wedeterminevisitseach6months.Thiscorrespondstoregularfollow-up.


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5.1.2 Communication

Communicationmust be adapted to language and comprehension impairment. As PLWDshavememory problems and fail to recollect things, persons or events, a brochure of thestudywill be given.During theproject, PLWDswill receive informationon the trial. If thePLWDisenrolled inthecontrolgroup,hecanstillexpecttoreceiveaccesstotheplatformonceparticipationintheclinicaltrialsends.

5.1.3 Engagement

An engagement experience is informative, constructive, and mutually beneficial. Mostimportantly,PLWDsandstakeholdersshouldthoroughlyvettheirengagementstrategiesatthe earliest possible stages. The Dialogue participants identified the following types ofquestionsthatbothresearchersandPLWDswillconsiderwhenevaluatingtheirengagementapproaches:

Table13:EngagementquestionnaireforPLWD

Q1 Whatarewetryingtoachieve?

A1 C-MMDwilldeterminespecificgoalsoftheengagementforPLWD

Q2 Whoarewetryingtoengage?

A2Explain who the target population or stakeholder group is and using thatassessmenttoinformselectionofwhombesttoengage

Q3 Whenshouldweengage?

A3 Identifyingwhatpointsalongagivenprocessareoptimalforeachengagement

Q4 Howshouldweengage?

A4 Selectingthemethodsmostsuitableforeachengagement

Q5 Whatistheexpectedimpact?

A5Developingoridentifyingmetrics(outcomesorendpoints)thatcanbeassessedtodeterminewhetheranengagementachievedtheoriginalgoals

Q6 Whatwastheactualimpact?

A6Implementing frequent checkpoints during and following the engagements toencouragecommunication,collectdataontheoutcomes/endpoints,andpromptlyaddressanyissues


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Furthermore, such consideration will offer a greater likelihood that an engagement orengagementstrategywillachievemaximumimpactandlikelybeconsideredmeaningfulbybothpatientsandstakeholders.

5.1.4 BuildconfidenceandtrustforPLWDs

To engage patients effectively and build their confidence, we will focus on the followingkeys:credibility,literacy,expectationmanagement,accessibilityrelatedtopeople.

5.1.4.1 Credibility

Wewillbuildcredibility,andspeaktopatientsinatrustedvoice.Theindustryhasseengreatresults when recruitmentmaterials include testimonials from patients or caregivers, whohave participated in focus groups or trials. In addition to testimonials, there are severalotherwaystobuildcredibility:

1. Takingempathyintoaccount2. Creatingandprovidingtoolsthatgiveafeelingofbeingastakeholderinthedisease

care3. CreatingandprovidingtoolstomakeiteasyforaPLWD’scircleofcaretobemore

involved in their loved ones journey, can further expand a sense of empathy andengagement.

5.1.4.2 Literacy

AccordingtotheDepartmentofHealth&HumanServices,only12%ofU.S.adultspossessproficient health literacy. One approach that is effective in addressing the challenge ofhealth literacy is creating interactive infographics of trial protocols. These infographicsprovideasimplevisualdepictionofoftencomplicatedschedulesthatmaketheinformationeasier tounderstand. These infographics arenotonlyuseful for patients, but also for sitestaffandinvestigators.

5.1.4.3 ExpectationManagement

FAQresponsesarewrittenandpresentedbynursesorotherpatients.

5.1.4.4 Accessibility

Clinicaltrialmaterialsareappropriatetoage,disease,sensory impairment.Thismaterial isshareableandsupportedbymultipledevices.

5.1.4.5 Reliability

CMMD-Prowillprovide informationthataresensitivetoculturalandgendernuances,andwillavoidimageryanddesignapproachesthatareoutoftouchwiththepatientpopulation.


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5.2 Strategyforcaregiver

5.2.1 Improvingconsent

For many caregivers, obtaining informed consent can be a barrier. In order to improveenrolmentinthestudy,inclusionandexclusioncriteriaarelargeinthisstudy.

Oneofthedifficultiesisrepresentedbythefactthatthecaregiversarecriticalpartnersandsupport assistance in the consent process. The burnout due to the caregiving may be areasontodeclineparticipation.

Toimproveenrolmentinthestudy,caregiversaremorelikelytoparticipateif:

Table14:KeyfactorstoimproveenrolmentforCaregivers


Clearcommunication

§ Caregiversreceiveclearinformationaboutthetrial.Thisinformationmustbeadaptedtotheroleofthecaregiverinthestudyandtothelevelofdisease(abrochurewithquestionsandanswers–FAQ-couldbegiventocaregivers)

§ ExpectedoutcomesforcaregiversandPLWDofthetrialarediscussed,

§ DirectindividualbenefitsoftheuseoftheCAREGIVERSPRO-MMDplatformarediscussedwithcaregivers.Directreturnoninvestmentisclearlyexplainedwithcaregivers.

§ Theyareclearlyinformedofethicalproceduresanddataprotection§ Adverseeventsarescarcecomparedtoadrugtrial.Theyare

explainedtothecaregiver.

Consistentfollowup

Thestudydesigniswellestablishedandfrequencyoffollow-upisdetailed.Wedeterminevisitseach6months.Thisfrequencycorrespondstotheregularfollow-up.

5.2.2 Communication

Caregiversmaybesurprisedtolearnthatenrolmentoftheirlovedoneintoaclinicaltrialalsomeansarealcommitmentontheirpart.

Ifthecaregiverisenrolledinthecontrolgroup,hecanstillexpecttoreceiveaccesstheplatformonceparticipationintheclinicaltrialsends.

5.2.3 EngagementTable15:EngagementquestionnaireforCaregivers

Q1 Whatarewetryingtoachieve?

A1 C-MMDwilldeterminespecificgoalsoftheengagementforPLWDandcaregiver


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Q2 Whoarewetryingtoengage?

A2Explain who the target population or stakeholder group is and using thatassessmenttoinformselectionofwhombesttoengage

Q3 Whenshouldweengage?

A3 Identifyingwhatpointsalongagivenprocessareoptimalforeachengagement

Q4 Howshouldweengage?

A4 Selectingthemethodsmostsuitableforeachengagement

Q5 Whatistheexpectedimpact?

A5Developingoridentifyingmetrics(outcomesorendpoints)thatcanbeassessedtodeterminewhetheranengagementachievedtheoriginalgoals

Q6 Whatwastheactualimpact?

A6Implementing frequent checkpoints during and following the engagements toencouragecommunication,collectdataontheoutcomes/endpoints,andpromptlyaddressanyissues

Furthermore, such consideration will offer a greater likelihood that an engagement orengagementstrategywillachievemaximumimpactandlikelybeconsideredmeaningfulbybothpatientsandstakeholders.

5.2.4 Buildconfidenceandtrustforcaregivers

To engage patients effectively and build their confidence, we will focus on the followingkeys:credibility,literacy,expectationmanagement,accessibilityandthatrelatestopeople.

5.2.4.1 Credibility

TheC-MMDteamwillbuildcredibility,andspeaktopatientsinatrustedvoice.Theindustryhas seen great results when recruitment materials include testimonials from patients orcaregivers, who have participated in a trial. In addition to testimonials, there are severalotherwaystobuildcredibility:

1- Takingempathyintoaccount2- Creatingandprovidingtoolstomakeiteasyforacaregiver’scircleofcaretobe

more involved and give a feeling of stakeholder in the care,that can furtherexpandasenseofempathyandengagement.


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5.2.4.2 Healthliteracy

AccordingtotheDepartmentofHealth&HumanServices,only12%ofU.S.adultspossessproficient health literacy. One approach that is effective in addressing the challenge ofhealth literacy is creating interactive infographics of trial protocols. These infographicsprovideasimplevisualdepictionofoftencomplicatedschedulesthatmaketheinformationeasier tounderstand. These infographics arenotonlyuseful for patients, but also for sitestaffandinvestigators.

5.2.4.3 ExpectationManagement

FAQresponsesarewrittenandpresentedbyhealthprofessionals.

5.2.4.4 Accessibility

Clinicaltrialmaterialsareageappropriate,shareableandsupportedbymultipledevices.

5.2.4.5 Reliability

C-MMDwill provide information that is sensitive to cultural and gendernuances, andwillavoidimageryanddesignapproachesthatareoutoftouchwiththepatientpopulation.

5.3 Strategyformedicaldoctors

Dependingontheroleofeachprofessional,differentstrategieswillbeadopted:

1- Screeningofthetotalactivefileofpatientswithneurocognitiveimpairmentwhoarefollowedbypsychologistsorspecialistsinvolvedinthepilotstudy.Professionalswillscreen:

o Inmemoryclinicso Inhospitaldaycareo Inhospitalization(rehabilitation,acutecare,etc.)

Ifpatientsmeettheinclusionandexclusioncriteria,theteamwillidentifyifthepatientandthecaregiveraccepttoparticipateinthestudy.

2- Informationwillbesenttohealthpartnersincloseproximitytothepilotstudy(medicaldoctors,psychologists,nurses,etc.).Thesehealthpartnerswillscreentheiractivefilesofpatientswithneurocognitivedisorders:

o Inmemoryclinicso Inhospitalo Inhospitaldaycareordaycarecentreso Inthecommunity

IfaPLWDandhiscaregivermeettheinclusioncriteria,thehealthprofessionalwillproposetothedyadtoparticipatenthestudy.Thisprofessionalwillcontacttheteaminvolvedinthestudy.Thecriteriawillbechecked.Ifthecriteriaareverified,anappointmentforthedyadwillbebookedwiththepilotteam.

3- Information will be sent to other health professionals (general practitioners,neurologists, psychiatrists, geriatricians, nurses, psychologists, etc.) in order to


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promoteawarenessofthestudy.Theywillreceiveanddisseminateinformationonthe trial (flyers, newsletter articles, information on web sites, public serviceannouncements,pressreleases,etc.)

Ateachstage,theroleofthepilothealthteamis:

- Toscreenactivefilesofpatientswithneurocognitiveimpairment- Tobeactivelyinvolvedinremindingnearbyhealthandsocialprofessionalsin

ordertoachieveinclusionintime.- Toverifytheinclusionandexclusioncriteria- TogiveclearinformationontheCMMD-ProPlatformandthestudyprotocol- Todiscussoutcomes,benefits/risks,roleandresponsibilitiesofeachpartner;- Toverifythewillingnesstocompletethestudy- Todescribethetimetableofthestudy- ToverifytheabilitytouseICT- Toobtaininformedconsent- Tofollowcompletionofthestudyanddealwithissues(dyadsthatdonotuse

theplatform,dyadswhichwanttowithdrawinformedconsent,etc.)

5.4 StrategyforsocialprofessionalsInneurocognitivedisorders,theroleofsocialworkersisimportant;theyoftenhavecloselinkswithmedicalteamsanddyads.Inthepilotstudy,theymayplaydifferentrolesforparticipationandcompletionofthestudy.

Theroleofsocialworkersmaybe:

1. screeningthetotalactivefileofpatientswithneurocognitiveimpairmentwhoarefollowedo Bysocialworkersinthecommunityo Inhospitalization(rehabilitation,acutecare,etc.)o Inmemoryclinicsordaycarecentres

2. givinginformationinordertopromotetheawarenessofthestudy.Theywillreceiveanddisseminateinformationonthetrial(flyers,newsletterarticles,informationonwebsites,publicserviceannouncements,pressreleases,etc.)

Ifpatientsmeettheinclusionandexclusioncriteria,theteamwillidentifyifthepatienthasacaregiverwhoacceptstoparticipateinthestudy.

Theroleofsocialworkeristomotivatethedyadtoparticipateandcompletethestudy.

IfaPLWDandhiscaregivermeettheinclusioncriteria,thehealthprofessionalwillproposetothedyadparticipationinthestudy.Thisprofessionalwillcontacttheteaminvolvedinthestudy.Thecriteriawillbechecked.Ifthecriteriaareverified,anappointmentforthedyadwillbebookedwiththepilotteam.


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Itisessentialthatthepilotteamhascloselinkswithsocialworkers.Therewillbecommunicationbetweenprofessionalsanddyadsthroughoutthestudy.Thisisessentialinthefollow-up.


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6 StrategyforRetentionThefirststepistofindthe«high-risk»dyadsinthestudy:strategiesusefultoinvestigatorswishingtoretainthese“high-risk”dyadsinthestudyprotocolinclude:screeningpatientsfordrop-outriskpriortorandomizationandtrackingthemcloselythroughoutthestudy.

The RAQ 7 item-scale (Research Attitude Questionnaire) (Rubright) is used to assess thewillingness of patients to participate and complete a study. This scale is not validated fortestinganICTdeviceindementiaandnocut-offisdefined.Thisscalemaybeausefultooltohelppilotteamstoselectdyadswhenadoubtispresent.

6.1 Categorizingparticipants

Initial randomization screening of participants on both demographic and psychologicalvariables (e.g. caregiver employment and educational status, caregiver depression, PLWDquality of life, etc.)may help identify those at greatest risk for studywithdrawal or poorstudy protocol adherence, permitting the C-MMD clinical team to develop retentionstrategiesaimedatthishigh-riskgroup.

Categorizing participants into separate groups based on completion status (on-timecompletersv.thosewitherraticstudyattendance)isausefuldataanalyticstrategy.

6.2 Possibleriskmitigationstrategies

Measuretominimizeparticipantburdenanddrop-out:

Table16:Retentionriskmitigationstrategies

Measure

Flexibleappointmentscheduling For“high-risk”dyads,proposeflexibleagenda.

Providingincentives

PeoplecankeeptabletprovidedbytheConsortiumoncestudyisdone.Forthecontrolgroupdyad:ifthedyadisenrolledinthecontrolgroup,itcanstillexpecttoreceiveplatformaccessonceparticipationintheclinicaltrialsends.

Socialsupport High-riskdyadswillbenefitfromsocialsupport

Contactbetweenappointments

High-riskdyadswillbecontactedbetweenappointments

Ifadyaddoesnotusetheplatformduringonemonth,aphonecontactwillbemadeinordertosolvethisissue

Createremindersforappointments


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Provideadetailedorientationsession Improvedcommunicationforhigh-riskdyads.

Provideuser-friendlyplatformIntegratepersonalisedsoftware

Gamificationstrategiestomotivateend-usertousetheplatform

ProvidecontentsProvidingusefulcontents,personalisedtocaregiversandPLWDisnecessarytominimizedrop-out

It is likely that the same factors predict patient clinic attendance and adherencewith themedical regimen. Consequently, identification of these risk factors as part of routine caremayhelp theC-MMDclinical teambetteraddress theparticular challenges facedbyhigh-riskdyads.


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7 ANNEXES7.1 Annex1:DSM-IVCriteriaAPA1994

A. Developmentofmultiplecognitivedefectsexpressedthrough:a. Memoryimpairmentb. Impairmentinoneormoreofthefollowingcognitivedomain

i. Aphasiaii. Apraxia(impairedabilitytocarryoutmotoractivitiesdespiteintact

motorfunction)iii. Agnosia(failuretorecognizeoridentifyobjectsiv. Executivefunctioning(planning,organization,abstraction…)

B. Cognitivedeficitscausesignificantimpairmentindailyfunction(social,occupational)andimplyasignificantdeclinefrompreviousleveloffunctioning.

C. ThecourseischaracterizedbygradualonsetandcontinuingcognitivedeclineD. Cognitivedefectsarenotdueto

a. Other central nervous system conditions that cause progressive deficits inmemoryandcognition

b. Systemicconditionsknowntocausedementiac. Substance-inducedconditions

E. DeficitsdonotoccurexclusivelyduringcourseofdeliriumF. Disturbance not better accounted for by another Axis I disorder (eg major

depressivedisorder,schizophrenia)

7.2 Annex2:MCI-Albert-Petersen2011

A- Complaintsconcerningachangeincognitionincomparisonwithpreviouslevel.Thiscomplaintcanbeobtainfromthepatient,theirfamilyorfromaskilledclinician

B- Impairment inoneormorecognitivedomain-Scoresarebelow1 to1.5 standarddeviation below the mean for their age and educational level. If repeatedevaluationsareavailable,adeclineinperformanceshouldbeevidentovertime.

C- Preservation of independence in functional abilities despite mild problems withcomplextasks(payingbills,cooking…)

D- Notdemented:Nosignificantimpairmentinsocialandoccupationalfunctioning

7.3 Annex3:ResearchAttitudeQuestionnaire-7item

• Ihaveapositiveviewaboutmedicalresearchingeneral• Medicalresearcherscanbetrustedtoprotecttheinterestsofpeoplewhotake

partintheirstudies


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• Wehavesomeresponsibilitytohelpothersbyvolunteeringformedicalresearch• Societyneedstodevotemoreresourcestomedicalresearch• Participatinginmedicalresearchisgenerallysafe• IfIvolunteerformedicalresearch,Iknowmypersonalinformationwillbekept

privateandconfidential• Medicalresearchwillfindcuresformajordiseaseduringmylifetime


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8 References1. MarilynS.Albert,StevenT.DeKosky,DennisDickson,BrunoDubois,HowardH.

Feldman,NickC.Fox,AnthonyGamst,DavidM.Holtzman,WilliamJ.Jagust,RonaldC.Petersen,PeterJ.Snyder,MariaC.Carrillo,BillThies,andCreightonH.Phelps.ThediagnosisofmildcognitiveimpairmentduetoAlzheimer’sdisease:RecommendationsfromtheNationalInstituteonAging-Alzheimer’sAssociationworkgroupsondiagnosticguidelinesforAlzheimer’sdisease.AlzheimersDement2011May7(3):270-279

2. AmericanPsychiatricAssociation.DiagnosticandStatisticalManualofMentalDisorders,4thedition.Washington,D.C.:AmericanPsychiatricPress,1994.

3. FolsteinMF, Folstein SE,McHugh PR. "Mini-mental state": a practicalmethod forgradingthecognitivestateofpatientsfortheclinician.JPsychiatrRes.1975;12:189-198.

4. RubrightJ,CaryM,KarlawishJ,KimS.Measuringhowpeopleviewbiomedicalresearch:reliabilityandvalidityanalysisoftheresearchattitudesquestionnaire.JEmpirResHumResEthics2011;6(1):63-68

5. GrillJD,K.J.AddressingthechallengestosuccessfulrecruitmentandretentionAlzheimer'sdiseaseclinicaltrials.AlzheimersResTher,2010;2(6),34.

6. CaryM,RubrightD,GrillJ,KarlawishJ.WhyarespousalcaregiversmoreprevalentthannonspousalcaregiversasstudypartnersinADdementiaclinicaltrials?AlzheimerDisAssocDisord2015;29(1):70-74.

7. AFA,AssociationFrançaisedesAidants.Lesprochesaidants:unequestionsociétale.Accompagnerpourpréserverlasanté[Internet].2016.Link:https://www.isere.fr/mda38/aider-aidants/Documents/Proches%20aidants.pdf

8. SpadinP,VaccaroCM.Lavitariposta:icostisocialiedeconomicidellamalattiadiAlzheimer[Internet].FrancoAngeli;2007.Link:http://www.alzheimer-aima.it/img/costieconomici_sintesi.pdf

9. RiveraJ,BermejoF,FrancoM,Morales-GonzálezJM,Benito-LeónJ.UnderstandingcareofpeoplewithdementiainSpain:Cohabitationarrangements,rotationandrejectiontolongtermcareinstitution.InternationalJournalofGeriatricPsychiatry.February2009;24(2):142-8.Link:http://onlinelibrary.wiley.com/doi/10.1002/gps.2081/full

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11. GrillJD,RamanR,ErnstromKetal.EffectofstudypartnerontheconductofAlzheimerdiseaseclinicaltrial.Neurology2013;80:282-288.

12. DodgeH,KatsumataY,ZhuJ,MattekN,BowmanM,GregoM,WildK,KayeJ.Characteristicsassociatedwithwillingnesstoparticipateinarandomizedcontrolledbehavioralclinicaltrialusinghome-basedpersonalcomputersandawebcam.Trials2014;15:508

13. JacovaC,HsiungG-YR,FeldmanHH.Dropoutsandrefusalsinobservationalstudies:lessonsforpreventiontrials.Neurology.November2006;67(9Suppl3):S17-20.Link:http://www.ncbi.nlm.nih.gov/pubmed/17101929

14. SmithGS.HandbookofDepressioninAlzheimer’sDisease.IOSPress2015.Link:http://www.iospress.nl/book/handbook-of-depression-in-alzheimers-disease/

15. VanMierloLD,MeilandFJM,VandeVenPM,VanHoutHPJ,DröesR-M.EvaluationofDEM-DISC,customizede-adviceonhealthandsocialsupportservicesforinformalcarersandcasemanagersofpeoplewithdementia;aclusterrandomizedtrial.IntPsychogeriatr.agostode2015;27(8):1365-78.Link:http://www.ncbi.nlm.nih.gov/pubmed/25872457

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