Clinical trial NCT05783414: Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support
Official title: Effectiveness and Cost-effectiveness of Virtually Delivered Cognitive Stimulation Therapy (vCST) and Online Dementia Carer Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
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
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: City University of Hong Kong
name: University of Auckland, New Zealand
name: London School of Economics and Political Science
name: Chinese University of Hong Kong
name: University College, London
First posted: 2023-03-24
Enrollment: 156
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive function
timeFrame: From T0 (baseline) to T1 (7 weeks)
measure: Change in quality of life in persons living with dementia
timeFrame: From T0 (baseline) to T1 (7 weeks)
measure: Change in self-efficacy
timeFrame: From T1 (7 weeks) to T2 (6 months post-CST)
Secondary outcomes:
measure: Change in behavioural and psychological symptoms of dementia
timeFrame: From T0 (baseline) to T2 (6 months post-CST)
measure: Change in functioning
timeFrame: From T0 (baseline) to T2 (6 months post-CST)
measure: Change in mental wellbeing (PLwD)
timeFrame: From T0 (baseline) to T1 (7 weeks)
measure: Change in carer burden
timeFrame: From T0 (baseline) to T2 (6 months post-CST)
measure: Change in mental wellbeing (carer)
timeFrame: From T0 (baseline) to T2 (6 months post-CST)
measure: Change in social functioning
timeFrame: From T0 (baseline) to T1 (7 weeks)
measure: Change in health-related quality of life (PLwD)
timeFrame: From T0 (baseline) to T1 (7 weeks)
measure: Change in perceived positive aspects of caregiving
timeFrame: From T1 (7 weeks) to T2 (6 months post-CST)
measure: Change in health-related quality of life (carer)
timeFrame: From T0 (baseline) to T2 (6 months post-CST)
Other outcomes:
measure: Extent to meet and attain a set of pre-agreed goals
timeFrame: 6 months
measure: Types and level of engagement
timeFrame: 7 weeks
measure: Change in spontaneous speech and discourse production
timeFrame: From T0 (baseline) to T1 (7 weeks)
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Gloria Wong, PhD
role: PRINCIPAL_INVESTIGATOR
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