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. 2019 May 14;2019(5):CD012533. doi: 10.1002/14651858.CD012533.pub2

NCT02806583.

Trial name or title Talking Time: telephone support groups for informal caregivers of people with dementia
Methods Cluster‐adjusted randomised controlled trial
Participants Caregivers 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, have access to a telephone connection for participation in the intervention and study evaluation. Exclusion criteria are lack of knowledge of the German language of informal caregiver, risk of suicide in the informal caregiver, actual psychiatric diagnosis of mental illness of the caregiver and ICD‐10 diagnosis of 'dementia in other diseases classified elsewhere', except dementia in primary Parkinson disease and Lewy Body disease.
Interventions Aim: The Talking Time project aims to close the supply gap (i.e. caregivers ability to attend on‐site support groups) by providing structured telephone‐based support groups in Germany for the first time.
Interventionist(s): no details provided
Mode of delivery: Telephone
Duration: Three months
Title of intervention: Telephone‐based structured support groups
Content:Telephone‐based Support Groups, information booklet, and telephone‐based preparatory meeting prior to the telephone‐based support groups
Standardisation: no details provided
Comparison group: Usual care (intervention as experimental group after T1 data collection (end of intervention, after 3 months).
Outcomes 1. Well‐being: Subjective well‐being using the Mental Component Summary of the General Health Questionaires Short Form 12 (SF‐12), psychological quality of life of the caregivers
2. Physical Component Summary of the SF‐12, physical quality of life of the caregivers
3. Social support: Perceived Social Support Caregiving Scale, perceived social support of the caregivers
4. Burden: Caregiver Reaction Scale, caregivers burden
Data were collected at baseline and T1 (end of intervention, the 3‐month time point).
Starting date November 2015
Contact information Martin Berwig, Dr. University of Leipzig email: martin.berwig@medizin.uni‐leipzig.de
Notes Dr. Berwig has confirmed that the trial is at the data analysis stage.