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Completed

NCT Number: NCT02806583

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig

Leipzig, Saxony, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

structured support groups

Other

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

Primary outcomes

  1. Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)

    Time frame: 3 months

    psychological quality of life of the caregivers

Secondary outcomes

  1. Physical Component Summary of the SF-12

    Time frame: 3 months

    physical quality of life of the caregivers

  2. Perceived Social Support Caregiving Scale

    Time frame: 3 months

    perceived social Support of the caregivers

  3. Caregiver Reaction Scale

    Time frame: 3 months

    caregivers burden

  4. Neuropsychiatric Inventory

    Time frame: 3 months

    neuropsychiatric symptoms of patients

Other outcomes

  1. General Practitioner assessment of COGnition (GPCOG)

    Time frame: Baseline

    cognitive abilities of Patient - Proxy rating

  2. Functional Activities Questionnaire

    Time frame: 3 months

    functional activities ability of patients

    functional activities ability of patients - proxy rating

  3. Patient Health Questionaire - 9 items (PHQ-9)

    Time frame: Baseline

    depression of caregivers

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Center for Neurodegenerative Diseases (DZNE)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2016
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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