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DementiaNCT05783414

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

A study testing f2f CST, f2f carer support and vCST in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dementia
What is being tested?
f2f CST, f2f carer support and vCST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteHong Kong
Study dates
1 Apr 2023to 5 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • unable to communicate;
  • unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong, 00000

Other trials in Hong Kong

About this study

Official title: 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

Read the 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.

Conditions
Dementia
Being tested
f2f CST, f2f carer support, vCST, online carer support
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
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • f2f CSTBehavioural

    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 supportBehavioural

    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.

  • vCSTBehavioural

    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 supportBehavioural

    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.

Study groups in NCT05783414
Study groupRoleWhat they receive
vCST + f2f carer supportExperimentalvCST followed by in-person carer support programme
Receives: Behavioral: f2f carer support; Behavioral: vCST
f2f CST + f2f carer supportActive comparatorIn-person CST followed by in-person carer support programme
Receives: Behavioral: f2f CST; Behavioral: f2f carer support
vCST + online carer supportExperimentalvCST followed by online carer support programme
Receives: Behavioral: vCST; Behavioral: online carer support
f2f CST + online carer supportExperimentalIn-person CST followed by online carer support programme
Receives: Behavioral: f2f CST; Behavioral: online carer support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From T0 (baseline) to T1 (7 weeks)

  2. 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).

    Measured: From T0 (baseline) to T1 (7 weeks)

  3. 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).

    Measured: From T1 (7 weeks) to T2 (6 months post-CST)

Secondary outcomes (9)

  1. 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).

    Measured: From T0 (baseline) to T2 (6 months post-CST)

  2. 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).

    Measured: From T0 (baseline) to T2 (6 months post-CST)

  3. 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).

    Measured: From T0 (baseline) to T1 (7 weeks)

  4. 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).

    Measured: From T0 (baseline) to T2 (6 months post-CST)

  5. Change in mental wellbeing (carer)

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

    Measured: From T0 (baseline) to T2 (6 months post-CST)

  6. 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).

    Measured: From T0 (baseline) to T1 (7 weeks)

  7. 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).

    Measured: From T0 (baseline) to T1 (7 weeks)

  8. 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).

    Measured: From T1 (7 weeks) to T2 (6 months post-CST)

  9. 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).

    Measured: From T0 (baseline) to T2 (6 months post-CST)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completion27 Nov 2024
  4. Study completion5 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783414
Sponsor's protocol ID
C7055-21GF
Status last verified
Mar 2025
First submitted
13 Mar 2023
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prince M, Bryce R, Ferri C, Alzheimer's Disease International. World Alzheimer Report 2011: The Benefits of Early Diagnosis and Intervention. London, UK: Alzheimer's Disease International; 2011.

  • Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2.

    PubMed 22336813

  • Knapp M, Thorgrimsen L, Patel A, Spector A, Hallam A, Woods B, Orrell M. Cognitive stimulation therapy for people with dementia: cost-effectiveness analysis. Br J Psychiatry. 2006 Jun;188:574-80. doi: 10.1192/bjp.bp.105.010561.

    PubMed 16738349

  • Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK513207/

    PubMed 30011160

  • Dai R, Zhang AY, Wong G. The impact of covid19 on formal and informal dementia care in Hong Kong. 34th International Conference of Alzheimer's Disease International; 2020.

  • Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.

    PubMed 11056778

  • Chan IW, Chu LW, Lee PW, Li SW, Yu KK. Effects of cognitive function and depressive mood on the quality of life in Chinese Alzheimer's disease patients in Hong Kong. Geriatr Gerontol Int. 2011 Jan;11(1):69-76. doi: 10.1111/j.1447-0594.2010.00643.x. Epub 2010 Aug 25.

    PubMed 20738410

  • Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27.

    PubMed 26016419

  • Sun Y, Luk TT, Wang MP, Shen C, Ho SY, Viswanath K, Chan SSC, Lam TH. The reliability and validity of the Chinese Short Warwick-Edinburgh Mental Well-being Scale in the general population of Hong Kong. Qual Life Res. 2019 Oct;28(10):2813-2820. doi: 10.1007/s11136-019-02218-5. Epub 2019 May 29.

    PubMed 31144205

  • Wong A, Cheng ST, Lo ES, Kwan PW, Law LS, Chan AY, Wong LK, Mok V. Validity and reliability of the neuropsychiatric inventory questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):247-52. doi: 10.1177/0891988714532017. Epub 2014 Apr 24.

    PubMed 24763069

  • Au A, Lai MK, Lau KM, Pan PC, Lam L, Thompson L, Gallagher-Thompson D. Social support and well-being in dementia family caregivers: the mediating role of self-efficacy. Aging Ment Health. 2009 Sep;13(5):761-8. doi: 10.1080/13607860902918223.

    PubMed 19882415

  • Judge KS, Camp CJ, Orsulic-Jeras S. Use of Montessori-based activities for clients with dementia in adult day care: Effects on engagement. American Journal of Alzheimer's Disease 2000; 15(1): 42-6.

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.

    PubMed 10945075

  • Lu S, Liu T, Wong GHY, Leung DKY, Sze LCY, Kwok WW, Knapp M, Lou VWQ, Tse S, Ng SM, Wong PWC, Tang JYM, Lum TYS. Health and social care service utilisation and associated expenditure among community-dwelling older adults with depressive symptoms. Epidemiol Psychiatr Sci. 2021 Feb 2;30:e10. doi: 10.1017/S2045796020001122.

    PubMed 33526166

Questions about this trial

What is this clinical trial studying?

A study testing f2f CST, f2f carer support and vCST in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive function (time frame: From T0 (baseline) to T1 (7 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05783414, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

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