Dementia
Conditions
Keywords
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
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.
Interventions
BEHAVIORALf2f CST
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.
BEHAVIORALf2f carer support
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.
BEHAVIORALvCST
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.
BEHAVIORALonline carer support
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.
Sponsors
City University of Hong Kong
University of Auckland, New Zealand
London School of Economics and Political Science
Chinese University of Hong Kong
University College, London
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The researchers performing the assessments will be blinded to the intervention group allocation.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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 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 (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 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 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Extent to meet and attain a set of pre-agreed goals | 6 months | The Goal Attainment Scale (GAS) would be used to record a set of goals the carer desires to achieve in T1 (7 weeks) and assess the extent of goal achievement in T2 (6 months). |
| Change in spontaneous speech and discourse production | From T0 (baseline) to T1 (7 weeks) | Change in spontaneous speech and discourse production in persons living with dementia assessed using short conversation, important event recall, and picture description from T0 (baseline) to T1 (7 weeks). |
| Types and level of engagement | 7 weeks | An observational tool of engagement adapted from the Myers Research Institute Engagement Scale (MRI-ES) would be used to assess the types and level of engagement of persons living with dementia during CST intervention. |
Countries
Hong Kong
Outcome results
None listed