Clinical trial NCT02806583: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia
Official title: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of People With Dementia
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Center for Neurodegenerative Diseases (DZNE)
First posted: 2016-06-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)
timeFrame: 3 months
Secondary outcomes:
measure: Physical Component Summary of the SF-12
timeFrame: 3 months
measure: Perceived Social Support Caregiving Scale
timeFrame: 3 months
measure: Caregiver Reaction Scale
timeFrame: 3 months
measure: Neuropsychiatric Inventory
timeFrame: 3 months
Other outcomes:
measure: General Practitioner assessment of COGnition (GPCOG)
timeFrame: Baseline
measure: Functional Activities Questionnaire
timeFrame: 3 months
measure: Patient Health Questionaire - 9 items (PHQ-9)
timeFrame: Baseline
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
state: Saxonia
Study officials:
affiliation: University of Leipzig
name: Martin Berwig, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
citation: Dichter MN, Albers B, Trutschel D, Strobel AM, Seismann-Petersen S, Wermke K, Halek M, Berwig M. TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone. BMC Health Serv Res. 2020 Aug 25;20(1):788. doi: 10.1186/s12913-020-05523-9.
citation: Berwig M, Dichter MN, Albers B, Wermke K, Trutschel D, Seismann-Petersen S, Halek M. Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project. BMC Health Serv Res. 2017 Apr 17;17(1):280. doi: 10.1186/s12913-017-2231-2.