Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)

September 17, 2020 updated by: University College, London

Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK) for People With Moderate to Severe Dementia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) translate and adapt ACST for the Chinese population; 3) evaluate the feasibility of Advanced Cognitive Stimulation Therapy - Hong Kong (ACST-HK). A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving the cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability. Developing an intervention targeting Chinese-the largest aging population-is also novel and allows ACST-HK to impact internationally from its infancy.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Illness and disability that affects participation (as deemed by researcher or attending
  2. care home staff)
  3. CMMSE < 5
  4. Participation in other psychosocial intervention studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Standard care in care homes
Experimental: Advanced Cognitive Stimulation Therapy Hong Kong

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
A modified version of Cognitive Stimulation Therapy for people with moderate to severe dementia translated and culturally adapted for the Hong Kong Chinese population.
Other Names:
  • ACST-HK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment (feasibility of ACST-HK)
Time Frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
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)
Time Frame: Descriptive data will be collected during the study and analysed post-intervention; at 8-week follow-up
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)
Time Frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
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)
Time Frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
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)
Time Frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: Pre test (baseline: week 0) and post test (week 8)
Exploratory primary outcome; measured pre and post intervention with Standardised Mini-Mental State Examination (Molloy & Standish, 1997) and Test for Severe Impairment (Albert & Cohen, 1992). SMMSE has 11 questions with scores from 0 to 30, where a low score indicates poor performance. TSI has six domains: motor performance, language comprehension, language production, memory, general knowledge, and conceptualisation. Each domain has a maximum score of 4, and a higher score indicates better cognitive ability.
Pre test (baseline: week 0) and post test (week 8)
Change in quality of life
Time Frame: Pre test (baseline: week 0) and post test (week 8)
Exploratory primary outcome; measured pre and post test with Quality of Life in Alzheimer's Disease (QoL-AD) (Logsdon et al., 2002). QoL-AD has 13-items, and a sum score range from 13 to 52; higher score denotes better quality of life.
Pre test (baseline: week 0) and post test (week 8)
Change in communication abilities
Time Frame: Pre test (baseline: week 0) and post test (week 8)
Exploratory secondary outcome; measured pre and post test with the Holden Communication Scale (Holden & Woods, 1995). Each item contains is on a 5 point scale, and the questionnaire has a maximum score of 48, where a higher score indicates difficulties in communication.
Pre test (baseline: week 0) and post test (week 8)
Change in engagement
Time Frame: Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
Exploratory secondary outcome; measured with the Group Observational Measurement of Engagement Tool (Cohen-Mansfield et al., 2017). GOME consists of 5-domains: attendance, engagement, active participation, attitude, and sleep. Each item is measured on a 4- or 7-point Likert scale from 0, none of the time, to 6, all of the time.
Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
Change in behaviour
Time Frame: Pre test (baseline: week 0) and post test (week 8)
Exploratory secondary outcome; measured pre and post test with the Cantonese Version of Neuropsychiatric Inventory (CNPI) (Cummings et al., 1997; Leung et al., 2001). CNPI consists of 12 domains. Each question asks for a frequency of symptoms on a 4-point score, severity on a 3-point score, and distress on a 5-point scale. Higher score denotes higher frequency and severity.
Pre test (baseline: week 0) and post test (week 8)
Change in overall well-being
Time Frame: Evaluated by assessor through video recordings for every session; week 1 to until end of study
Exploratory secondary outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney & Rentz, 2005). The facilitator or independent researcher will assess 4 participants at a time. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect.
Evaluated by assessor through video recordings for every session; week 1 to until end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Aimee Spector, PhD, DClinPsych, University College, London
  • Principal Investigator: Gloria Wong, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2006026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study results will be published in peer-reviewed journals, and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion.

IPD Sharing Time Frame

Upon study completion.

IPD Sharing Access Criteria

Email authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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