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

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
f2f CST
f2f carer support
vCST
online carer support
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring 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

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

vCST + f2f carer support

f2f CST + f2f carer support

vCST + online carer support

f2f CST + online carer support

Arm Description

vCST followed by in-person carer support programme

In-person CST followed by in-person carer support programme

vCST followed by online carer support programme

In-person CST followed by online carer support programme

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).
Change in mental wellbeing (carer)
Change in mental wellbeing in carers measured using the WEMWBS from T0 (baseline) to T2 (6 months).
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).
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).
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).
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).

Full Information

First Posted
March 13, 2023
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05783414
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
June 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The researchers performing the assessments will be blinded to the intervention group allocation.
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vCST + f2f carer support
Arm Type
Experimental
Arm Description
vCST followed by in-person carer support programme
Arm Title
f2f CST + f2f carer support
Arm Type
Active Comparator
Arm Description
In-person CST followed by in-person carer support programme
Arm Title
vCST + online carer support
Arm Type
Experimental
Arm Description
vCST followed by online carer support programme
Arm Title
f2f CST + online carer support
Arm Type
Experimental
Arm Description
In-person CST followed by online carer support programme
Intervention Type
Behavioral
Intervention Name(s)
f2f CST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
f2f carer support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
vCST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
online carer support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)
Title
Change in quality of life in persons living with dementia
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)
Title
Change in self-efficacy
Description
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).
Time Frame
From T1 (7 weeks) to T2 (6 months post-CST)
Secondary Outcome Measure Information:
Title
Change in behavioural and psychological symptoms of dementia
Description
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).
Time Frame
From T0 (baseline) to T2 (6 months post-CST)
Title
Change in functioning
Description
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).
Time Frame
From T0 (baseline) to T2 (6 months post-CST)
Title
Change in mental wellbeing (PLwD)
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)
Title
Change in carer burden
Description
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).
Time Frame
From T0 (baseline) to T2 (6 months post-CST)
Title
Change in mental wellbeing (carer)
Description
Change in mental wellbeing in carers measured using the WEMWBS from T0 (baseline) to T2 (6 months).
Time Frame
From T0 (baseline) to T2 (6 months post-CST)
Title
Change in social functioning
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)
Title
Change in health-related quality of life (PLwD)
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)
Title
Change in perceived positive aspects of caregiving
Description
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).
Time Frame
From T1 (7 weeks) to T2 (6 months post-CST)
Title
Change in health-related quality of life (carer)
Description
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).
Time Frame
From T0 (baseline) to T2 (6 months post-CST)
Other Pre-specified Outcome Measures:
Title
Extent to meet and attain a set of pre-agreed goals
Description
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).
Time Frame
6 months
Title
Types and level of engagement
Description
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.
Time Frame
7 weeks
Title
Change in spontaneous speech and discourse production
Description
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).
Time Frame
From T0 (baseline) to T1 (7 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Leung, MS
Phone
39170080
Email
emleung@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Jacky Choy, PhD
Phone
39170079
Email
cpchoy@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Wong, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Wong, PhD
Phone
39172074
Email
ghywong@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support

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