ClinicalTrials.Veeva

Menu

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

U

University of Leipzig

Status

Completed

Conditions

Caregivers of People With Dementia

Treatments

Other: structured support groups

Study type

Interventional

Funder types

Other

Identifiers

NCT02806583
932 000 - 151

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

intervention
Experimental group
Description:
telephone based structured support groups
Treatment:
Other: structured support groups
control
No Intervention group
Description:
Active Comparator: Usual care (intervention as experimental group after 3 month (after T1)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems