Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia
NCT ID: NCT02806583
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2015-11-30
2017-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intervention
telephone based structured support groups
structured support groups
Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
control
Active Comparator: Usual care (intervention as experimental group after 3 month (after T1)
No interventions assigned to this group
Interventions
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structured support groups
Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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German Center for Neurodegenerative Diseases (DZNE)
OTHER
University of Leipzig
OTHER
Responsible Party
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Dr. Martin Berwig
Project Leader
Principal Investigators
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Martin Berwig, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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University of Leipzig
Leipzig, Saxony, Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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932 000 - 151
Identifier Type: -
Identifier Source: org_study_id