Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support
1 other identifier
interventional
156
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2024
CompletedMarch 21, 2025
March 1, 2025
1.7 years
March 13, 2023
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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).
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).
From T1 (7 weeks) to T2 (6 months post-CST)
Secondary Outcomes (9)
Change in behavioural and psychological symptoms of dementia
From T0 (baseline) to T2 (6 months post-CST)
Change in functioning
From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (PLwD)
From T0 (baseline) to T1 (7 weeks)
Change in carer burden
From T0 (baseline) to T2 (6 months post-CST)
Change in mental wellbeing (carer)
From T0 (baseline) to T2 (6 months post-CST)
- +4 more secondary outcomes
Other Outcomes (3)
Extent to meet and attain a set of pre-agreed goals
6 months
Types and level of engagement
7 weeks
Change in spontaneous speech and discourse production
From T0 (baseline) to T1 (7 weeks)
Study Arms (4)
vCST + f2f carer support
EXPERIMENTALvCST followed by in-person carer support programme
f2f CST + f2f carer support
ACTIVE COMPARATORIn-person CST followed by in-person carer support programme
vCST + online carer support
EXPERIMENTALvCST followed by online carer support programme
f2f CST + online carer support
EXPERIMENTALIn-person CST followed by online carer support programme
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- unable to communicate;
- unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- City University of Hong Kongcollaborator
- University of Auckland, New Zealandcollaborator
- London School of Economics and Political Sciencecollaborator
- Chinese University of Hong Kongcollaborator
- University College, Londoncollaborator
Study Sites (1)
The University of Hong Kong
Hong Kong, 00000, Hong Kong
Related Publications (15)
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.
BACKGROUNDWoods 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.
PMID: 22336813BACKGROUNDKnapp 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.
PMID: 16738349BACKGROUNDDementia: 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/
PMID: 30011160BACKGROUNDDai 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.
BACKGROUNDChu 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.
PMID: 11056778BACKGROUNDChan 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.
PMID: 20738410BACKGROUNDTang 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.
PMID: 26016419BACKGROUNDSun 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.
PMID: 31144205BACKGROUNDWong 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.
PMID: 24763069BACKGROUNDAu 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.
PMID: 19882415BACKGROUNDJudge 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.
BACKGROUNDHerdman 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.
PMID: 21479777BACKGROUNDChisholm 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.
PMID: 10945075BACKGROUNDLu 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.
PMID: 33526166BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria Wong, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The researchers performing the assessments will be blinded to the intervention group allocation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
April 1, 2023
Primary Completion
November 27, 2024
Study Completion
December 5, 2024
Last Updated
March 21, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share