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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02806583
Enrollment
38
Registered
2016-06-20
Start date
2015-11-30
Completion date
2017-05-31
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers of People With Dementia

Brief 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.

Interventions

OTHERstructured support groups

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

Sponsors

German Center for Neurodegenerative Diseases (DZNE)
CollaboratorOTHER
University of Leipzig
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)3 monthspsychological quality of life of the caregivers

Secondary

MeasureTime frameDescription
Perceived Social Support Caregiving Scale3 monthsperceived social Support of the caregivers
Physical Component Summary of the SF-123 monthsphysical quality of life of the caregivers
Caregiver Reaction Scale3 monthscaregivers burden
Neuropsychiatric Inventory3 monthsneuropsychiatric symptoms of patients

Other

MeasureTime frameDescription
Patient Health Questionaire - 9 items (PHQ-9)Baselinedepression of caregivers
Functional Activities Questionnaire3 monthsfunctional activities ability of patients functional activities ability of patients - proxy rating
General Practitioner assessment of COGnition (GPCOG)Baselinecognitive abilities of Patient - Proxy rating

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026