Dementia Clinical Trial
Official title:
A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia
Verified date | May 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a mixed-methods research that includes a single-blind three-arms randomized control trials and a focus group study. The quantitative study aims to investigate the additional clinical benefits of the Six Arts intervention over an evidence-based non-pharmacological intervention translated from western culture, cognitive stimulation therapy (CST). The qualitative part aims to explore the acceptance and understanding of family caregiver of the Six Arts intervention and CST. It is hypothesized that 1) the group who have received Six Arts intervention would show superior quality of life; 2) both Six Arts and CST groups would show superior cognitive improvement compared with usual care; 3) the Six Arts group would show greater improvement in behavioral and neuropsychological symptoms and functioning compared with the groups receiving CST or usual care.
Status | Completed |
Enrollment | 216 |
Est. completion date | December 29, 2021 |
Est. primary completion date | December 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | People with dementia: Inclusion Criteria: - aged 60 or above - have clinical diagnosis of dementia or a Clinical Dementia Rating (CDR) of 1-2 suggestive of mild-to-moderate disease; - able to communicate and understand communication, see and hear well enough to participate in a meaningful assessment; - person with dementia and/or his/her caregiver can provide informed consent Exclusion Criteria: - suffering from major physical illness or disability that affect participation; - had experience with the 24-session of CST or Six Arts intervention protocols Caregivers (for the focus group study) Inclusion Criteria: - provide care to the person of dementia for more than 8 hours per week - have observed at least one intervention session of either CST or Six Arts intervention |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong | Non-US Or Canadian Address |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Chinese University of Hong Kong, Hong Kong Alzheimer's Disease Association |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in quality of life of people with dementia | measure by using a 13-item self-rating and proxy rating scale, the Quality of Life in Alzheimer's Disease (QoL-AD) | T0 (baseline), T1 (up to 4 months) | |
Primary | Changes in cognitive performance | measure by using the Alzheimer's Disease Assessment Scale - Cognitive section (ADAS-Cog), a standard cognitive test commonly used in clinical trials for people with dementia | T0 (baseline), T1 (up to 4 months) | |
Secondary | CDAD | measure the changes in functioning by using the Chinese version of the Disability Assessment for Dementia (CDAD), a 11-item scale that evaluates the basic and instrumental activities in daily activities of elderly people with dementia | T0 (baseline), T1 (up to 4 months) | |
Secondary | NPI-Q | measure the changes in behavioral and psychological symptoms of dementia by using the Neuropsychological Inventory Questionnaire (NPI-Q), a 12-item informant-based interview | T0 (baseline), T1 (up to 4 months) |
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