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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783414
• Other study ID #: C7055-21GF
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 29, 2024

Study information

• Verified date: November 2022
• Source: The University of Hong Kong
• Contact: Emily Leung, MS
• Phone: 39170080
• Email: emleung[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (6)

Lead Sponsor	Collaborator
The University of Hong Kong	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

Country where clinical trial is conducted

Hong Kong, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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/ — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extent to meet and attain a set of pre-agreed goals	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
Other	Types and level of engagement	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
Other	Change in spontaneous speech and discourse production	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)
Primary	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)
Primary	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)
Primary	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	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).	From T0 (baseline) to T2 (6 months post-CST)
Secondary	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).	From T0 (baseline) to T2 (6 months post-CST)
Secondary	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).	From T0 (baseline) to T1 (7 weeks)
Secondary	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).	From T0 (baseline) to T2 (6 months post-CST)
Secondary	Change in mental wellbeing (carer)	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)
Secondary	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).	From T0 (baseline) to T1 (7 weeks)
Secondary	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).	From T0 (baseline) to T1 (7 weeks)
Secondary	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).	From T1 (7 weeks) to T2 (6 months post-CST)
Secondary	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).	From T0 (baseline) to T2 (6 months post-CST)