Caregivers of People With Dementia Clinical Trial
Official title:
Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Caring for people with dementia (PwD) at home requires an enormous amount of time,
organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD
often feel a high burden. Even though support groups on-site have shown positive effects on
the subjective well-being and on the perceived social support of ICs, relatives either have
no time or opportunity to leave the PwD alone or there are no support groups in the vicinity.
The Talking Time project therefore aims to close this supply gap by providing structured
telephone-based support groups in Germany for the first time. International studies have
shown resulting benefits for ICs.
Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled
trial. The effects of the 3-months Talking Time intervention will be compared to a normal
care group. Outcomes will be measured at two different times (baseline = T0, after 3 months
=T1). The control group will receive the Talking Time intervention after T1.
ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on
four days per week in the last six months. Exclusion criteria are psychiatric disorders of
the IC.
Primary outcome of the effectiveness elevation is the subjective well-being of the relatives
measured by the mental component of the SF-12. Secondary outcomes are the physical component
summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction
Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative
and qualitative data sources will be collected addressing reach, fidelity, and dosage.
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