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| Name | Class |
|---|---|
| German Center for Neurodegenerative Diseases (DZNE) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | telephone based structured support groups |
|
| control | No Intervention | Active Comparator: Usual care (intervention as experimental group after 3 month (after T1) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured support groups | Other | Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General Practitioner assessment of COGnition (GPCOG) | cognitive abilities of Patient - Proxy rating | Baseline |
| Functional Activities Questionnaire | functional activities ability of patients functional activities ability of patients - proxy rating |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Berwig, Dr. | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33417236 | Derived | Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3. | |
| 32838773 | Derived | Dichter MN, Albers B, Trutschel D, Strobel AM, Seismann-Petersen S, Wermke K, Halek M, Berwig M. TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone. BMC Health Serv Res. 2020 Aug 25;20(1):788. doi: 10.1186/s12913-020-05523-9. |
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| 3 months |
| Caregiver Reaction Scale | caregivers burden | 3 months |
| Neuropsychiatric Inventory | neuropsychiatric symptoms of patients | 3 months |
| 3 months |
| Patient Health Questionaire - 9 items (PHQ-9) | depression of caregivers | Baseline |
| 28415999 | Derived | Berwig M, Dichter MN, Albers B, Wermke K, Trutschel D, Seismann-Petersen S, Halek M. Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project. BMC Health Serv Res. 2017 Apr 17;17(1):280. doi: 10.1186/s12913-017-2231-2. |