|- candidate number||6579|
|- NTR Number||NTR2051|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-okt-2009|
|- Secondary IDs||NL27434.097.09, versie 3 METIGG CCMO-nr|
|- Public Title||Effectiveness of an e-Mental Health intervention for family caregivers of people with dementia |
|- Scientific Title||Effectiveness of an eHealth intervention on psychological well-being, feelings of burden and perceived health of family caregivers of people with dementia|
|- hypothesis||The e-Mental Health intervention has a positive effect on psychological well-being, feelings of burden and perceived health of family caregivers of people with dementia. This effect will last for several months after finishing the intervention. |
|- Healt Condition(s) or Problem(s) studied||Dementia, Depression, Depressive symptoms, Informal care-givers, Caregiver burden, Family caregivers, Psychological Intervention, e-Mental Health|
|- Inclusion criteria||(1) informed consent given; (2) insufficient knowledge or computer skills; (3) depressive symptoms in specific range (CES-D score: 12-26). |
|- Exclusion criteria||(1) severe psychiatric problems for which immediate treatment or referral is needed; (2) current treatment for psychiatric problems; (3) suidical thoughts.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||31-mei-2009|
|- planned closingdate||30-nov-2010|
|- Target number of participants||150|
|- Interventions||The experimental group receives an innovative e-Mental Health intervention, called ‘Dementie de Baas’ (‘Mastery over Dementia’). The intervention consist of 8 lessons and a booster session (follow-up). Working principles are psycho education, cognitive behavioral therapy, problem solving behavior, assertiveness training and relaxation therapy. Participants are in contact with a professional counselor (digital coach) who gives them feedback. The control group receives a minimal intervention. The participants will receive a serie of information bulletins sent every two weeks by e-mail. There is no contact with a professional counsellor. |
|- Primary outcome||Depressive symtoms as measured by the CES-D. |
|- Secondary outcome||Symptoms of anxiety (HADS), caregiver stress (RPBMC) and feelings of burden (SPICC). Other measures are self-perceived competence , subjective health, quality of life, use of care services and time spent on care.|
|- Timepoints||Baseline, after 4 lessons/bulletins, after finishing the intervention (both experimental and control group). Experimental group again 3 months and 6 months after finishing the intervention. |
|- Trial web site||www.dementiedebaas.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.M. Pot|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.M. Pot|
|- Sponsor/Initiator ||VU University Medical Center, Department of Clinical Psychology, NIMHA,|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Clinical Psychology, Netherlands Institute of Mental health and Addiction, Univé (Health Insurance), Geriant, Alzheimer Nederland|
|- Brief summary||INTRODUCTION|
‘Dementiedebaas.nl’ (or in English ‘Mastery over Dementia’) is a recently developed internet course for family caregivers of people with dementia under the guidance of a psychologist. The intervention is focused on the empowerment of family caregivers with the aim to improve their psychological well-being in general and reduce their depressive symptoms in particular. Family caregivers were closely involved in the development.
The aim of the proposed study is to evaluate the (cost)effectiveness of ‘Dementiedebaas.nl’. Research questions are: 1a. Will the intervention generate superior health gains over care-as-usual in terms of a clinically significant change in depressive symptoms, symptoms of anxiety and feelings of burden? 1b. And will these effects be maintained up to 6 months after the intervention? 2. Will the intervention be cost-effective in comparison with “care-as-usual” for QALYs gained?
Mastery over Dementia focuses on assisting caregivers to help themselves in preventing depressive symptoms as much as possible under the guidance of a coach. After a course consisting of 8 sessions and a booster session, ongoing forum participation and free access to the course and their file is offered. Caregivers can be reached in an early stage of the care giving process, including those who have not sought help for the person with dementia yet. The intervention incorporates elements of psycho-education, cognitive behavioral therapy, problem solving therapy, relaxation therapy and assertiveness training. Interactive feedback is given by a coach.
The study is a pragmatic randomized controlled trial with two parallel groups. The control group will receive bulletins with practical information via mail at regular intervals. Measurements will be conducted in both conditions at baseline (T=0), after the fourth lesson or bulletin (T=1) and after the ninth lesson or bulletin (T=2). Maximum time interval between T0 and T2 is set at 26 weeks. The intervention group will receive prolonged measurements at 3 and 6 months after T2 to monitor effect maintenance over time.
The primary outcome is depressive symptoms. Secondary outcomes are symptoms of anxiety, feelings of competencies, self-perceived pressure from informal care and health-related quality of life.
Analysis will be conducted following the intention-to-treat principle. Missing values on T1 and T2 because of drop-out will be imputed on the basis of regression analysis. Multivariate linear regression analysis will be used to answer research question 1a. Generalized estimated equations (GEE) analysis will be conducted to answer research question 1b. Research question 2 will be answered by using costs utility analysis for a period of six months.
|- Main changes (audit trail)|
|- RECORD||11-okt-2009 - 9-feb-2010|