University of Leipzig
Leipzig, Saxony, 04103, Germany
NCT Number: NCT02806583
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Leipzig, Saxony, 04103, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
Time frame: 3 months
psychological quality of life of the caregivers
Time frame: 3 months
physical quality of life of the caregivers
Time frame: 3 months
perceived social Support of the caregivers
Time frame: 3 months
caregivers burden
Time frame: 3 months
neuropsychiatric symptoms of patients
Time frame: Baseline
cognitive abilities of Patient - Proxy rating
Time frame: 3 months
functional activities ability of patients
functional activities ability of patients - proxy rating
Time frame: Baseline
depression of caregivers
University of Leipzig
Other
Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
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