Abstract
BackgroundCaring for a family member with dementia is extremely stressful, and contributes to psychiatric and physical illness among caregivers. Therefore, a comprehensive programme called Resources for Enhancing Alzheimer’s Caregiver Health II (REACH II) was developed in the United States to enhance the health of Alzheimer’s caregivers. REACH II causes a clear reduction of the stress and burdens faced by informal caregivers at home. The aim of this protocol is to adapt, apply, and evaluate this proven intervention programme in a German-speaking area for the first time. This newly adapted intervention is called Deutsche Adaption der Resources for Enhancing Alzheimer’s Caregiver Health (DeREACH).MethodsA total of 138 informal caregivers at home are recruited in a single-centred, randomised controlled trial. The intervention (DeREACH) consists of nine home visits and three telephone contacts over six months, all of which focus on safety, psychological well-being and self-care, social support, problem behaviour and preventive health-related behaviours. A complex intervention assessment on effectiveness will be adopted when the primary outcome – namely, the reduction of caregiver burden – and other secondary outcomes, including changes with regard to anxiety and depression, somatisation, health-related quality of life, and perceived social support, are measured at baseline, as well as immediately and three months after the intervention. The change from baseline to post-intervention assessment with regard to the primary outcome will be compared between treatment and control group using t-tests for independent samples.DiscussionIt is anticipated that this study will show that DeREACH effectively reduces caregiver burden and therefore works under the conditions of a local German health-care system. If successful, this programme will provide an effective intervention programme in the German-speaking area to identify and develop the personal capabilities of informal caregivers to cope with the burdens of caring for people with dementia.Trial registrationNCT01690117
Highlights
Caring for a family member with dementia is extremely stressful, and contributes to psychiatric and physical illness among caregivers
We address potential participants via articles and announcements in newspapers and via posters and flyers that are available in several health-care facilities
The study described in this paper is the first study in Germany to investigate the effectiveness of the adapted REACH programme
Summary
Study design The study has been designed as a non-blinded, randomised, and controlled trial. Study staff will make another appointment for the first home visit with the informal caregivers allocated to the intervention group. The informal caregivers of the control group only receive the standard supply of health care services and the assessments outlined above. Outcomes Demographic information from the informal caregivers as well as from the people with dementia will be gathered via a questionnaire during the baseline assessment In this trial, the outcome of primary interest is the effect on the burden of care-giving. The change from baseline to post-intervention assessment (six months) on the ZBI (primary outcome) will be compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Participation is voluntary and all participants will sign informed consent
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