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Internet-based self-management support for family caregivers to manage behaviour changes of their relative with dementia


- candidate number26498
- NTR NumberNTR6237
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2017
- Secondary IDs80-80705-98-027; 2016.559 ZonMw; METC VUMC Amsterdam
- Public TitleInternet-based self-management support for family caregivers to manage behaviour changes of their relative with dementia
- Scientific TitleInternet-based self-management support for family caregivers to manage behaviour changes of their relative with dementia
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedDementia, Informal care-givers
- Inclusion criteriaThe study population will consist of participants who meet the following inclusion criteria. The family caregiver:
- is a family member of a person diagnosed with dementia (all subtypes possible);
- has to have contact with a person with dementia at least once a week;
- The person with dementia has to live at home (not in a care institution);
- has access to the Internet on a daily basis and has basic skills in using internet and e-mail;
- is 18 years or older.
- Exclusion criteriaFamily caregivers will be excluded if they do not meet the inclusion criteria.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2018
- Target number of participants72
- InterventionsThis study concerns internet-based self-management support intervention for family caregivers of persons with dementia which will be tested in three intervention-arms. It is developed in collaboration with VUmc, NIVEL, Dutch Alzheimer’s Society, Trimbos-institute and Geriant.

The three intervention-arms are:
1. Large intervention-arm, consisting of
- personal e-coaching by a nurse specialised in dementia care structured according to the 5 steps in the 5 A’s Behavior Change Model (5 A’s Model). These five steps are: 1) Assess; 2) Advise; 3) Agree; 4) Assist, and 5) Arrange.;
- video-based support with assessments;
- provision of e-bulletins about managing behaviour changes.
2. Medium intervention-arm, consisting of
- video-based support with assessments;
- the provision of the afore mentioned e-bulletins.

3. Small intervention-arm, consisting of
- provision of the mentioned e-bulletins
- Primary outcomeSelf-efficacy measured with ‘Trust in Own Abilities’ (TOA)
- Secondary outcome- The Revised Memory and Behavioral Problem Checklist (RMBPC) will be used to assess the presence and the number of behaviour and mood problems of the person with dementia (reported by the family caregiver)
- The Dyadic Relationship Scale (DRS) will be used to measure the impact of providing family care on the family caregiver.
- TimepointsData will be collected via internet at baseline (T0), 6 weeks after baseline (T1) and 12 weeks after baseline (T2).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. A. Francke
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Francke
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute, NIVEL, Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Dutch Alzheimer’s Society, Geriant
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-jan-2017 - 12-apr-2017


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