Clinical Trials Directory

Trials / Completed

CompletedNCT02806583

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
University of Leipzig · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERstructured support groupsTelephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups

Timeline

Start date
2015-11-01
Primary completion
2017-03-13
Completion
2017-05-01
First posted
2016-06-20
Last updated
2017-10-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02806583. Inclusion in this directory is not an endorsement.