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The Development and Evaluation of a Culturally Tailored Support Group Program on the Psychosocial Wellbeing of Family Caregivers of Individuals Living With Dementia in Hong Kong

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cultivate yourself: support for caregivers of dementia persons
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participants should be the family members who care for a relative with dementia at home. The eligibility criteria include:

    1. Chinese;
    2. aged > 18 years;
    3. the ability to communicate in Chinese / Cantonese; and
    4. voluntary participation.

Exclusion Criteria:

  • The exclusion criteria include those currently suffering from a psychiatric illness with/without regular follow-up or treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cultivate yourself: support for caregivers of dementia persons

    Arm Description

    There will be six sessions (1 or 2 session per week). The duration of each session will be 1.5-2 hours per session. The contents include: introduction on dementia, caregivers' role, how to communicate with dementia persons, tips on caregiving, stress and emotional management. The training content has been verified by one social worker, family caregivers of individuals living with dementia and a teacher who teach Chinese, Chinese history and culture in the secondary school in Hong Kong. No adverse comments are received from them.

    Outcomes

    Primary Outcome Measures

    SSQ6
    • The SSQ6 was used to investigate the quantity of support each participant obtains as well as their satisfaction with the support provided. The participants will be asked to indicate from 0-9 the number of support persons they have for the six situations and rate their overall satisfaction with the support provided using a six-point scale. High SSQ6 satisfaction scores mean more satisfaction with social support received.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2020
    Last Updated
    April 3, 2020
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04334200
    Brief Title
    The Development and Evaluation of a Culturally Tailored Support Group Program on the Psychosocial Wellbeing of Family Caregivers of Individuals Living With Dementia in Hong Kong
    Official Title
    The Development and Evaluation of a Culturally Tailored Support Group Program on the Psychosocial Wellbeing of Family Caregivers of Individuals Living With Dementia in Hong Kong
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Hong Kong is also facing the increasing prevalence of dementia. Evidence states that dementia caregivers have poor psychosocial wellbeing including stress, depression and anxiety. Effective services and interventions should be provided to the caregivers to improve their psychosocial wellbeing. Recent studies suggest that cultural adapted intervention is necessary. Such intervention can support caregivers to improve psychosocial wellbeing by using the culture and rituals to relevant racial caregivers creatively. Among all interventions for dementia caregivers, it was reported that the support group/program was more effective to improve psychosocial well-being of dementia caregivers. However, the studies about support group for dementia caregivers did not report the cultural sensitivity elements explicitly. Most of them mention the component 'language' only. Other elements, including philosophical thoughts, had not been mentioned in the articles. It is necessary to provide more cultural components including philosophical thoughts in the support groups. Moreover, the studies did not report on the benefits of adding cultural elements in the interventions to dementia caregivers. Although the literature mentioned cultural adapted interventions were beneficial, the research on understanding its benefits is inadequate. More caregiver intervention studies to understand the advantages of cultural tailoring are needed. Hence, we need to do more studies to understand the benefits of adding cultural elements in the interventions to caregivers. A research is performed to develop and evaluate a culturally adapted intervention for dementia caregivers to improve their psychosocial wellbeing. This research study is to evaluate the effectiveness and benefits of culturally tailored interventions for caregivers of older adults with dementia on improving psychosocial well-being. Mixed method and quasi-experimental design will be applied. There are 2 groups: intervention and control groups. Each group needs to complete pre and post-test to assess their psychosocial well-beings. The pre and post-test data will be used for assessing the effectiveness of the culturally tailored intervention program for the dementia caregivers. For intervention group, qualitative data, i.e. data from focus group interview will be performed to assess the benefits of inclusion of cultural elements in the program.
    Detailed Description
    A quasi-experimental study will be performed to assess the effectiveness and benefits of a culturally tailored support group programs for Chinese dementia caregivers. The PhD candidate will contact three non-governmental organizations (NGO), including Rotary Club that provides dementia services to dementia persons or their caregivers in the elderly centres. The caregivers will be recruited as participants through these centres. A quasi-experimental, non-equivalent pre-test-post-test control group design will be used to determine the effectiveness of a culturally tailored support group program. A non-equivalent control group design was used because caregivers from the same centre would have known each other. If caregivers in each elderly centre were randomly assigned to experimental and control groups, there may have been a chance that caregivers in the experimental group would discuss the intervention with caregivers in the control group. Also, the caregivers in the control group may think it was unfair that they do not have a chance to have the culturally tailored support group programs. Hence, a quasi-experimental design will be implemented and the experimental and control groups will be from different elderly centres. The participants should be the family members who care for a relative with dementia at home. The eligibility criteria include: Chinese; aged > 18 years; the ability to communicate in Chinese / Cantonese; and voluntary participation. The exclusion criteria include those currently suffering from a psychiatric illness with/without regular follow-up or treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Intervention group receiving support group program
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    49 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cultivate yourself: support for caregivers of dementia persons
    Arm Type
    Experimental
    Arm Description
    There will be six sessions (1 or 2 session per week). The duration of each session will be 1.5-2 hours per session. The contents include: introduction on dementia, caregivers' role, how to communicate with dementia persons, tips on caregiving, stress and emotional management. The training content has been verified by one social worker, family caregivers of individuals living with dementia and a teacher who teach Chinese, Chinese history and culture in the secondary school in Hong Kong. No adverse comments are received from them.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cultivate yourself: support for caregivers of dementia persons
    Intervention Description
    The Chinese cultural values, including philosophical thoughts, will be included in the intervention. Chinese philosophical thoughts including the concepts of moderation, improving oneself, and harmony with nature will be used in the intervention. Confucianism, Taoism and Buddhism are the foundation for Chinese for concepts of health and illness, health promotion, and health-seeking behavior. Therefore, it is necessary to incorporate such philosophies in the sessions of the program.
    Primary Outcome Measure Information:
    Title
    SSQ6
    Description
    • The SSQ6 was used to investigate the quantity of support each participant obtains as well as their satisfaction with the support provided. The participants will be asked to indicate from 0-9 the number of support persons they have for the six situations and rate their overall satisfaction with the support provided using a six-point scale. High SSQ6 satisfaction scores mean more satisfaction with social support received.
    Time Frame
    1.5 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participants should be the family members who care for a relative with dementia at home. The eligibility criteria include: Chinese; aged > 18 years; the ability to communicate in Chinese / Cantonese; and voluntary participation. Exclusion Criteria: The exclusion criteria include those currently suffering from a psychiatric illness with/without regular follow-up or treatment.

    12. IPD Sharing Statement

    Learn more about this trial

    The Development and Evaluation of a Culturally Tailored Support Group Program on the Psychosocial Wellbeing of Family Caregivers of Individuals Living With Dementia in Hong Kong

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