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Completed

NCT Number: NCT05783414

Effectiveness and Cost-effectiveness of 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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, 00000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

f2f CST

Behavioral

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.

f2f carer support

Behavioral

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.

vCST

Behavioral

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.

online carer support

Behavioral

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 outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

Other outcomes

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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