Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Cost-effectiveness of Virtually Delivered Cognitive Stimulation Therapy (vCST) and Online Dementia Carer Support

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: f2f CST
* Behavioral: f2f carer support
* Behavioral: vCST
* Behavioral: online carer support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: unable to communicate; unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vCST + f2f carer support<br>vCST followed by in-person carer support programme | Behavioral: f2f carer support<br>* 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.<br>Behavioral: vCST<br>* 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.<br>|
| Active Comparator: f2f CST + f2f carer support<br>In-person CST followed by in-person carer support programme | Behavioral: f2f CST<br>* 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.<br>Behavioral: f2f carer support<br>* 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.<br>|
| Experimental: vCST + online carer support<br>vCST followed by online carer support programme | Behavioral: vCST<br>* 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.<br>Behavioral: online carer support<br>* 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.<br>|
| Experimental: f2f CST + online carer support<br>In-person CST followed by online carer support programme | Behavioral: f2f CST<br>* 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.<br>Behavioral: online carer support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | From T1 (7 weeks) to T2 (6 months post-CST) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | From T0 (baseline) to T2 (6 months post-CST) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive stimulation therapy (CST), virtually delivered cognitive stimulation therapy (vCST), carer support programme, information and communication technology (ICT), cluster randomised trial, effectiveness, cost-effectiveness, Chinese