Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial

Conditions
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Caregivers of People With Dementia

Intervention / Treatment
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* Other: structured support groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>telephone based structured support groups | Other: structured support groups<br>* Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups<br>|
| No Intervention: control<br>Active Comparator: Usual care (intervention as experimental group after 3 month (after T1) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) | psychological quality of life of the caregivers | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Component Summary of the SF-12 | physical quality of life of the caregivers | 3 months | 
| Perceived Social Support Caregiving Scale | perceived social Support of the caregivers | 3 months | 
| Caregiver Reaction Scale | caregivers burden | 3 months | 
| Neuropsychiatric Inventory | neuropsychiatric symptoms of patients | 3 months |