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

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783414

Collaborator

City University of Hong Kong (Other), University of Auckland, New Zealand (Other), London School of Economics and Political Science (Other), Chinese University of Hong Kong (Other), University College, London (Other)

156

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: f2f CST Behavioral: f2f carer support Behavioral: vCST Behavioral: online carer support	N/A

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). We will measure outcomes at baseline, 7 weeks, and 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The researchers performing the assessments will be blinded to the intervention group allocation.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 29, 2024

Anticipated Study Completion Date :

Jun 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vCST + f2f carer support vCST followed by in-person carer support programme	Behavioral: f2f 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. Behavioral: vCST 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.
Active Comparator: f2f CST + f2f carer support In-person CST followed by in-person carer support programme	Behavioral: f2f 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. Behavioral: f2f 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.
Experimental: vCST + online carer support vCST followed by online carer support programme	Behavioral: vCST 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. Behavioral: online 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.
Experimental: f2f CST + online carer support In-person CST followed by online carer support programme	Behavioral: f2f 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. Behavioral: online 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.

Outcome Measures

Primary Outcome Measures

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 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).

Secondary Outcome Measures

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).
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 Warwich-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 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).
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).

Other Outcome Measures

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).
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

participants with a clinical diagnosis of mild to moderate dementia and their family carers living in the community in Hong Kong;
able to communicate and understand communication, see and hear well enough to participate in a meaningful assessment;
person with dementia and/or his/her caregiver can provide informed consent

Exclusion Criteria:

participants that are unable to communicate and participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions.