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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
156
An evidence-based group CST protocol adapted for Hong Kong Chinese culture. It consists of 14 sessions of group activities (group size: 6) for people with mild to moderate dementia, where participants with similar level of cognitive impairment receive cognitively stimulating social activities twice per week over 7 weeks.
Centre-based carer support programme for dementia carers provided in a community care service centre, which provide group education on caring skills, mutual support groups, and group-based self-care training over 6 months.
A home-based version of f2f CST delivered via an information and communication technology platform (Zoom plus a web-based CST platform). It consists of 14 sessions of group activities (group size: 3) for people with mild to moderate dementia, where participants with similar level of cognitive impairment receive cognitively stimulating social activities twice per week over 7 weeks.
The University of Hong Kong
Hong Kong, Hong Kong
Change in cognitive function
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).
Time frame: From T0 (baseline) to T1 (7 weeks)
Change in quality of life in persons living with dementia
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).
Time frame: From T0 (baseline) to T1 (7 weeks)
Change in self-efficacy
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).
Time frame: From T1 (7 weeks) to T2 (6 months post-CST)
Change in behavioural and psychological symptoms of dementia
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).
Time frame: From T0 (baseline) to T2 (6 months post-CST)
Change in functioning
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).
Time frame: From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (PLwD)
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).
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A home-based carer support service delivered via an information and communication technology platform (Zoom plus a web-based carer platform). It consists of 4 group sessions (group size: 6) and 3 individual sessions, and 3 optional self-learning sessions over 6 months, with an empowering care management approach to strengthen carer self-efficacy.
Time frame: From T0 (baseline) to T1 (7 weeks)
Change in carer burden
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).
Time frame: From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (carer)
Change in mental wellbeing in carers measured using the WEMWBS from T0 (baseline) to T2 (6 months).
Time frame: From T0 (baseline) to T2 (6 months post-CST)
Change in social functioning
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).
Time frame: From T0 (baseline) to T1 (7 weeks)
Change in health-related quality of life (PLwD)
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).
Time frame: From T0 (baseline) to T1 (7 weeks)
Change in perceived positive aspects of caregiving
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).
Time frame: From T1 (7 weeks) to T2 (6 months post-CST)
Change in health-related quality of life (carer)
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).
Time frame: From T0 (baseline) to T2 (6 months post-CST)