Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical ICD-10 dementia diagnosis available for the patient (F00.-*: Alzheimer disease or related disorders, F01.-: Vascular dementia, F03.-:Unspecified dementia)
- •living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively
- •access to a telephone connection to be able to participate in the talking Time Intervention and the telephone- based interviews for the evaluation
排除标准
- •lack of knowledge of German Language of informal caregiver
- •risk of suicide in the informal caregiver
- •actual psychiatric diagnosis of mental illness of the caregiver
- •ICD-10-diagnosis of Dementia in other diseases classified elsewhere (F02.-*), except Dementia in Primary Parkinson disease (F02.3*) and Lewy Body disease (F02.8/G31.82)
研究组 & 干预措施
intervention
telephone based structured support groups
干预措施: structured support groups (Other)
control
Active Comparator: Usual care (intervention as experimental group after 3 month (after T1)
结局指标
主要结局
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)
时间窗: 3 months
psychological quality of life of the caregivers
次要结局
- Perceived Social Support Caregiving Scale(3 months)
- Neuropsychiatric Inventory(3 months)
- Physical Component Summary of the SF-12(3 months)
- Caregiver Reaction Scale(3 months)
研究者
Dr. Martin Berwig
Project Leader
University of Leipzig