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

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.

Study Overview

• Status: Completed
• Conditions: Caregivers of People With Dementia
• Intervention / Treatment: Other: structured support groups

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxonia
    • Leipzig, Saxonia, Germany, 04103
      • University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; telephone based structured support groups	Other: structured support groups; Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
No Intervention: control; Active Comparator: Usual care (intervention as experimental group after 3 month (after T1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)	psychological quality of life of the caregivers	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Component Summary of the SF-12	physical quality of life of the caregivers	3 months
Perceived Social Support Caregiving Scale	perceived social Support of the caregivers	3 months
Caregiver Reaction Scale	caregivers burden	3 months
Neuropsychiatric Inventory	neuropsychiatric symptoms of patients	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Practitioner assessment of COGnition (GPCOG)	cognitive abilities of Patient - Proxy rating	Baseline
Functional Activities Questionnaire	functional activities ability of patients functional activities ability of patients - proxy rating	3 months
Patient Health Questionaire - 9 items (PHQ-9)	depression of caregivers	Baseline

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: German Center for Neurodegenerative Diseases (DZNE)
• Investigators: Principal Investigator: Martin Berwig, Dr., University of Leipzig

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): March 13, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 932 000 - 151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO