Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support
- Conditions
- Dementia
- Interventions
- Behavioral: f2f carer supportBehavioral: f2f CSTBehavioral: vCSTBehavioral: online carer support
- Registration Number
- NCT05783414
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
A multicentre single-blind cluster randomised trial to evaluate the effectiveness and cost-effectiveness of virtually delivered versus in-person cognitive stimulation therapy (CST) and carer support in people living with dementia and carers
- Detailed Description
This is a multicentre, single-blind cluster randomised trial with an aim to evaluate the effectiveness and cost-effectiveness of virtual delivery of CST and carer support in comparison with in-person CST and carer support in Hong Kong Chinese. A total of 156 dyads of people living with dementia and carers will be randomly assigned to one of the four groups: (A) vCST (7 weeks) followed by in-person carer support programme (6 months); (B) in-person CST (7 weeks) followed by in-person carer support programme (6 months); (C) vCST (7 weeks) followed by online carer support programme (6 months); and (D) in-person CST (7 weeks) followed by online carer support programme (6 months). The investigators will measure outcomes at baseline, 7 weeks, and 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- having a clinical diagnosis of mild to moderate dementia;
- having a family carer;
- living in the community in Hong Kong;
- able to communicate and understand communication;
- able to see and hear well enough to participate in a meaningful assessment;
- the person with dementia and/or his/her carer can provide informed consent
- unable to communicate;
- unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vCST + f2f carer support f2f carer support vCST followed by in-person carer support programme f2f CST + f2f carer support f2f carer support In-person CST followed by in-person carer support programme vCST + f2f carer support vCST vCST followed by in-person carer support programme f2f CST + online carer support f2f CST In-person CST followed by online carer support programme f2f CST + f2f carer support f2f CST In-person CST followed by in-person carer support programme vCST + online carer support vCST vCST followed by online carer support programme vCST + online carer support online carer support vCST followed by online carer support programme f2f CST + online carer support online carer support In-person CST followed by online carer support programme
- Primary Outcome Measures
Name Time Method Change in quality of life in persons living with dementia From T0 (baseline) to T1 (7 weeks) Change in quality of life in persons living with dementia measured using the 13-item Quality of Life in Alzheimer's Disease (QoL-AD) from T0 (baseline) to T1 (7 weeks).
Change in self-efficacy From T1 (7 weeks) to T2 (6 months post-CST) Change in self-efficacy in dementia carers measured using the Chinese Revised Scale for Caregiving Self-Efficacy (CSE-R) from T1 (7 weeks) to T2 (6 month post-CST).
Change in cognitive function From T0 (baseline) to T1 (7 weeks) Change in cognitive function in persons living with dementia measured using the Chinese version of the Alzheimer's Disease Assessment Scale - Cognitive section (ADAS-Cog) from T0 (baseline) to T1 (7 weeks).
- Secondary Outcome Measures
Name Time Method Change in perceived positive aspects of caregiving From T1 (7 weeks) to T2 (6 months post-CST) Change in perceived positive aspect of caregiving in carers measured using the Positive Aspect of Caregiving Scale (PAC) from T1 (7 weeks) to T2 (6 months post-CST).
Change in health-related quality of life (carer) From T0 (baseline) to T2 (6 months post-CST) Change in health-related quality of life in carers measured using the EQ-5D-5L, a self-rating and proxy-rating scale, from T0 (baseline) to T2 (6 months post-CST).
Change in mental wellbeing (PLwD) From T0 (baseline) to T1 (7 weeks) Change in mental wellbeing in the persons living with dementia measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), which has been validated in Hong Kong and used in people living with dementia, from T0 (baseline) to T1 (7 weeks).
Change in behavioural and psychological symptoms of dementia From T0 (baseline) to T2 (6 months post-CST) Change in behavioural and psychological symptoms of dementia measured using the Neuropsychological Inventory Questionnaire (NPI-Q), a 12-item informant-based interview from T0 (baseline) to T2 (6 months post-CST).
Change in health-related quality of life (PLwD) From T0 (baseline) to T1 (7 weeks) Change in health-related quality of life in the persons living with dementia measured using the EQ-5D-5L, a self-rating and proxy-rating scale, from T0 (baseline) to T1 (7 weeks).
Change in functioning From T0 (baseline) to T2 (6 months post-CST) Change in functioning of the persons living with dementia measured using the Chinese version of the Disability Assessment for Dementia (CDAD), an informant-based assessment, from T0 (baseline) to T2 (6 months post-CST).
Change in carer burden From T0 (baseline) to T2 (6 months post-CST) Change in carer burden measured using the Chinese 12-item version Zarit Burden Interview (CZBI) in carer from T0 (baseline) to T2 (6 months post-CST).
Change in mental wellbeing (carer) From T0 (baseline) to T2 (6 months post-CST) Change in mental wellbeing in carers measured using the WEMWBS from T0 (baseline) to T2 (6 months).
Change in social functioning From T0 (baseline) to T1 (7 weeks) Change in social functioning in the persons living with dementia measured using the Hong Kong version of Social Functioning in Dementia Scale (HKSF-DEM), a self-rating and proxy rating scale, from T0 (baseline) to T1 (7 weeks).
Trial Locations
- Locations (1)
The University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong