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

March 18, 2025 updated by: The University of Hong Kong

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)
Change in quality of life in persons living with dementia
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)
Change in self-efficacy
Time Frame: 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).
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
Time Frame: 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).
From T0 (baseline) to T2 (6 months post-CST)
Change in functioning
Time Frame: 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).
From T0 (baseline) to T2 (6 months post-CST)
Change in carer burden
Time Frame: 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).
From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (carer)
Time Frame: 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).
From T0 (baseline) to T2 (6 months post-CST)
Change in social functioning
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)
Change in health-related quality of life (PLwD)
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)
Change in perceived positive aspects of caregiving
Time Frame: 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).
From T1 (7 weeks) to T2 (6 months post-CST)
Change in health-related quality of life (carer)
Time Frame: 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).
From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (PLwD)
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent to meet and attain a set of pre-agreed goals
Time Frame: 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).
6 months
Types and level of engagement
Time Frame: 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.
7 weeks
Change in spontaneous speech and discourse production
Time Frame: 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).
From T0 (baseline) to T1 (7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

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

Investigators

  • Principal Investigator: Gloria Wong, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C7055-21GF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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