DementiaNCT04334200
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
A study testing Cultivate yourself: support for caregivers of dementia persons in people with Dementia, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Cultivate yourself: support for caregivers of dementia persons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria include those currently suffering from a psychiatric illness with/without regular follow-up or treatment.
About this study
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Cultivate yourself: support for caregivers of dementia persons
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultivate yourself: support for caregivers of dementia personsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cultivate yourself: support for caregivers of dementia persons | Experimental | 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. Receives: Behavioral: Cultivate yourself: support for caregivers of dementia persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group receiving support group program
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiu Hing Cheung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334200
- Sponsor's protocol ID
- 2019.565
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04334200
- Acronym / sponsor ID
- 2019.565
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group receiving support group program
| Arm | Type | Receives |
|---|---|---|
| Cultivate yourself: support for caregivers of dementia persons | Experimental | Behavioral: Cultivate yourself: support for caregivers of dementia personsThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participants should be the family members who care for a relative with dementia at home. The eligibility criteria include:
Key exclusion criteria (1 listed)
- The exclusion criteria include those currently suffering from a psychiatric illness with/without regular follow-up or treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultivate yourself: support for caregivers of dementia personsThe 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. | Behavioural | Cultivate yourself: support for caregivers of dementia persons |
Primary outcome
SSQ6
Time frame: 1.5 month
• 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cultivate yourself: support for caregivers of dementia persons in people with Dementia, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSQ6 (time frame: 1.5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.