NCT05394584

Brief Summary

This cluster wait-list randomized controlled study investigates the effectiveness of Cognitive Stimulation Therapy (Hong Kong version) delivered by trained supportive staff and volunteers for people in maintaining the quality of life and cognition in people with mild-to-moderate cognitive impairment in community and residential care settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

May 17, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

Cognitive Stimulation TherapyCognitive FunctioningPsychological Wellbeing

Outcome Measures

Primary Outcomes (2)

  • Quality of Life in Alzheimer's Disease

    A 13-item scale for self-rating and proxy rating on the quality of life of persons with dementia. The total score ranges from 3 to 52, higher scores means a better outcome.

    Change from Baseline Quality of Life in Alzheimer's Disease at 8 weeks

  • Alzheimer's Disease Assessment Scale- Cognitive Subscale

    A cognitive function assessment scale for people with dementia covering 11 cognitive domains. The total score ranges from 0 to 70, higher score represents worse outcome.

    Change from Baseline Alzheimer's Disease Assessment Scale- Cognitive Subscale at 8 weeks

Study Arms (2)

CST group

EXPERIMENTAL

A total of 64 people with mild-to-moderate cognitive impairment will receive group cognitive stimulation therapy (CST), which consists of 14 sessions of mentally stimulating activities delivered two times a week for 7 weeks by supportive staff and volunteers trained in CST, on top of their usual care in community centres or residential care homes.

Behavioral: Cognitive Stimulation Therapy

Usual care group

NO INTERVENTION

A total of 64 people with mild-to-moderate cognitive impairment will receive the usual care in community centres or residential care homes.

Interventions

Cognitive stimulation therapy is a non-pharmacological intervention for people with dementia at mild to moderate stages. Group cognitive stimulation therapy is a 14-session intervention delivered twice every week for 7 weeks. In each session, mentally stimulating activities are conducted around a specific themed, such as current affairs, word association, categorising objects, and number game. Each group consists of eight people with similar levels of cognitive impairment, facilitated by two group leaders who lead the activities according to 18 key principles of the therapy, including new associations, opinions rather than facts, implicit learning, and person-centred.

CST group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a clinical diagnosis of mild-to-moderate dementia, or a cognitive assessment result suggestive of mild-to-moderate cognitive impairment;
  • Being able to communicate and understand Cantonese;
  • Being able to hear and see well enough to participate in cognitive stimulation activities;
  • Having a caregiver who is able to give joint informed consent.

You may not qualify if:

  • Having major illness(es) that would affect participation (e.g., clinically significant depressive symptoms or psychotic disorders);
  • Having behavioural and psychological symptoms (e.g., aggression, inappropriate sexual behaviours, hallucination, delusion) that would interfere with participation in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Young Women's Christian Association

Hong Kong, 999077, Hong Kong

Location

Related Publications (19)

  • Aguirre E, Woods RT, Spector A, Orrell M. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials. Ageing Res Rev. 2013 Jan;12(1):253-62. doi: 10.1016/j.arr.2012.07.001. Epub 2012 Aug 7.

    PMID: 22889599BACKGROUND
  • Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD003260. doi: 10.1002/14651858.CD003260.pub2.

    PMID: 23740535BACKGROUND
  • 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.

    PMID: 20738410BACKGROUND
  • 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.

    PMID: 11056778BACKGROUND
  • Hall L, Orrell M, Stott J, Spector A. Cognitive stimulation therapy (CST): neuropsychological mechanisms of change. Int Psychogeriatr. 2013 Mar;25(3):479-89. doi: 10.1017/S1041610212001822. Epub 2012 Nov 12.

    PMID: 23146408BACKGROUND
  • Khan Z, Corbett A, Ballard C. Cognitive stimulation therapy: training, maintenance and implementation in clinical trials. Pragmat Obs Res. 2014 Apr 5;5:15-19. doi: 10.2147/POR.S56000. eCollection 2014.

    PMID: 27774025BACKGROUND
  • Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

    PMID: 12021425BACKGROUND
  • National Collaborating Centre for Mental Health (UK). Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care. Leicester (UK): British Psychological Society (UK); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK55459/

    PMID: 21834193BACKGROUND
  • Orrell M, Hoe J, Charlesworth G, Russell I, Challis D, Moniz-Cook E, Knapp M, Woods B, Hoare Z, Aguirre E, Toot S, Streater A, Crellin N, Whitaker C, d'Amico F, Rehill A. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) - evidence, development and evaluation of complex interventions. Southampton (UK): NIHR Journals Library; 2017 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK424174/

    PMID: 28211659BACKGROUND
  • Paddick SM. Cognitive stimulation therapy as a low-resource intervention for dementia in sub-saharan africa: Initial results of a controlled trial. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 11(7):607, 2015.

    BACKGROUND
  • Prince M, Bryce R, Ferri C. World Alzheimer Report 2011: The benefits of early diagnosis and intervention. Alzheimer's Disease International (ADI) 2011.

    BACKGROUND
  • Prince M, Wimo A, Guerchet M, Ali G, Wu Y, Prina M. World Alzheimer Report 2015-The Global Impact of Dementia: An analysis of prevalence, incidence, cost and trends. Alzheimer's Disease International (ADI) 2015.

    BACKGROUND
  • Spector A, Orrell M, Woods B. Cognitive Stimulation Therapy (CST): effects on different areas of cognitive function for people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1253-8. doi: 10.1002/gps.2464.

    PMID: 20069533BACKGROUND
  • Spector A, Thorgrimsen L, Woods B, Orrell M. Making a difference: An evidence-based group program to offer cognitive stimulation therapy (CST) to people with dementia; the manual for group leaders (text in chinese). Hong Kong: Hong Kong University Press 2017.

    BACKGROUND
  • Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.

    PMID: 12948999BACKGROUND
  • World Health Organization. Dementia: a public health priority. World Health Organization 2012.

    BACKGROUND
  • Wong GHY, Yek OPL, Zhang AY, Lum TYS, Spector A. Cultural adaptation of cognitive stimulation therapy (CST) for Chinese people with dementia: multicentre pilot study. Int J Geriatr Psychiatry. 2018 Jun;33(6):841-848. doi: 10.1002/gps.4663. Epub 2017 Jan 11.

    PMID: 29717527BACKGROUND
  • 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.

    PMID: 22336813BACKGROUND
  • Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14.

    PMID: 23097740BACKGROUND

Study Officials

  • Hoi Yan Gloria Wong, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a cluster randomized wait-list control study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 27, 2022

Study Start

June 1, 2018

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations