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

Caregivers of People With Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806583
• Other study ID #: 932 000 - 151
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: October 6, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Caregivers of People With Dementia
• Dementia

Intervention

Other:
• structured support groups
Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups

Locations

Country	Name	City	State
Germany	University of Leipzig	Leipzig	Saxonia

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General Practitioner assessment of COGnition (GPCOG)	cognitive abilities of Patient - Proxy rating	Baseline
Other	Functional Activities Questionnaire	functional activities ability of patients; functional activities ability of patients - proxy rating	3 months
Other	Patient Health Questionaire - 9 items (PHQ-9)	depression of caregivers	Baseline
Primary	Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)	psychological quality of life of the caregivers	3 months
Secondary	Physical Component Summary of the SF-12	physical quality of life of the caregivers	3 months
Secondary	Perceived Social Support Caregiving Scale	perceived social Support of the caregivers	3 months
Secondary	Caregiver Reaction Scale	caregivers burden	3 months
Secondary	Neuropsychiatric Inventory	neuropsychiatric symptoms of patients	3 months