Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)

NCT04555629 | Unknown

• 1 other identifier: EA2006026
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a feasibility randomized controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia in Hong Kong. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST), translated and adapted for the Hong Kong Chinese population, and developed within the Medical Research Council (MRC) framework.

Conditions

Dementia; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Frontal; Dementia Severe; Dementia Moderate; Dementia of Alzheimer Type

Keywords

Dementia; Randomized Controlled Trial; Cognitive Stimulation; Moderate to severe dementia

Outcome Measures

Primary Outcomes (5)

• Recruitment (feasibility of ACST-HK)

  Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.

  Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

• Retention rate (feasibility of ACST-HK)

  Retention rate of at least 75% of participants at 8-week follow-up.

  Descriptive data will be collected during the study and analysed post-intervention; at 8-week follow-up

• Negative of adverse events (acceptability of ACST-HK)

  Any negative or adverse events related to the intervention

  Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

• Intervention fidelity (acceptability of ACST-HK)

  Facilitator's completion of the fidelity checklist following each session

  Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

• Intervention fidelity (acceptability of ACST-HK)

  Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.

  Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Secondary Outcomes (6)

• Change in cognitive function

  Pre test (baseline: week 0) and post test (week 8)

• Change in quality of life

  Pre test (baseline: week 0) and post test (week 8)

• Change in behaviour

  Pre test (baseline: week 0) and post test (week 8)

• Change in engagement

  Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months

• Change in overall well-being

  Evaluated by assessor through video recordings for every session; week 1 to until end of study

Study Arms (2)

Advanced Cognitive Stimulation Therapy Hong Kong

EXPERIMENTAL

Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK), a psychosocial intervention, is the modified version of CST for people with moderate and severe dementia. Activities consist of more multisensory stimulation elements than the original CST. It has also been translated and adapted for the Hong Kong Chinese population. ACST-HK will be prescribed to participants 45-minutes per week, biweekly for 7 weeks. The intervention will be delivered by two facilitators, such as a research staff, clinical psychologist trainee, or care home staff.

Other: Advanced Cognitive Stimulation Therapy Hong Kong

Treatment as usual

NO INTERVENTION

Standard care in care homes

Interventions

Advanced Cognitive Stimulation Therapy Hong Kong OTHER

A modified version of Cognitive Stimulation Therapy for people with moderate to severe dementia translated and culturally adapted for the Hong Kong Chinese population.

Also known as: ACST-HK

Advanced Cognitive Stimulation Therapy Hong Kong

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Diagnosis of dementia, according to the DSM-V
• CMMSE ≤ 12
• Ability to communicate in English
• Ability to complete outcome measures
• Not having major physical illness or disability that affects participation
• Consultee willing and able to provide written informed consent, if participant is not able to provide consent.
• Ability to remain in a group for around an hour (e.g. no challenging behaviour)

You may not qualify if:

• Illness and disability that affects participation (as deemed by researcher or attending
• care home staff)
• CMMSE \< 5
• Participation in other psychosocial intervention studies

Sponsors & Collaborators

• University College, London: lead
• The University of Hong Kong: collaborator

Related Publications (9)

• 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: 12021425 BACKGROUND

• Albert M, Cohen C. The Test for Severe Impairment: an instrument for the assessment of patients with severe cognitive dysfunction. J Am Geriatr Soc. 1992 May;40(5):449-53. doi: 10.1111/j.1532-5415.1992.tb02009.x.

  PMID: 1634695 BACKGROUND

• Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

  PMID: 9153155 BACKGROUND

• Wood S, Cummings JL, Hsu MA, Barclay T, Wheatley MV, Yarema KT, Schnelle JF. The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000 Winter;8(1):75-83. doi: 10.1097/00019442-200002000-00010.

  PMID: 10648298 BACKGROUND

• Cohen-Mansfield J, Hai T, Comishen M. Group engagement in persons with dementia: The concept and its measurement. Psychiatry Res. 2017 May;251:237-243. doi: 10.1016/j.psychres.2017.02.013. Epub 2017 Feb 6.

  PMID: 28214783 BACKGROUND

• Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.

  PMID: 16136845 BACKGROUND

• Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.

  PMID: 11536346 BACKGROUND

• Chiu H, Lee HC, Chung WS, Kwong PK. Reliability and validity of the Cantonese Version of Mini-Mental State Examination - a preliminary study. JHKCPsych. 1994;4(2).

  BACKGROUND

• Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.

  BACKGROUND

Related Links

• International Cognitive Stimulation Therapy Centre Website

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Mixed Dementias; Lewy Body Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Aimee Spector, PhD, DClinPsych

  University College, London

  PRINCIPAL INVESTIGATOR

• Gloria Wong, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther K Hui, BSc

CONTACT

+85264643261; esther.hui.19@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind. Assessor will be blinded to the study. Due to the nature of the intervention, the facilitator and participants cannot be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 21, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon study completion.
• Access Criteria: Email authors.