- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334200
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cultivate yourself: support for caregivers of dementia persons
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1.5 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.565
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Cultivate yourself: support for caregivers of dementia persons
-
Queen's University, BelfastFour Seasons Health CareUnknownNeurodegenerative Diseases | DementiaUnited Kingdom
-
wen yu Kuo, assistant professorChang Gung Memorial Hospital; National Science and Technology CouncilCompleted
-
University of Massachusetts, WorcesterNational Institute on Aging (NIA); University of Utah; Boston CollegeActive, not recruitingPalliative Care | Interdisciplinary Communication | Caregivers | Deprescriptions | Hospices | Poly Pharmacy | Prescription Drug OveruseUnited States
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting