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DementiaNCT04555629

Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)

A study testing Advanced Cognitive Stimulation Therapy Hong Kong in people with Dementia and Dementia, Vascular, run by University College, London.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia, Dementia, Vascular, Dementia, Mixed
What is being tested?
Advanced Cognitive Stimulation Therapy Hong Kong
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
1 Nov 2020to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Esther K Hui, BSc contact

+85264643261

esther.hui.19@ucl.ac.uk

About this study

Official title: 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.

Read the 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.

Being tested
Advanced Cognitive Stimulation Therapy Hong Kong
Keywords
Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia
Medical subject headings
Dementia, Dementia, Vascular, Mixed Dementias, Lewy Body Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced Cognitive Stimulation Therapy Hong KongOther

    Also called ACST-HK

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

Study groups in NCT04555629
Study groupRoleWhat they receive
Advanced Cognitive Stimulation Therapy Hong KongExperimentalAdvanced 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.
Receives: Other: Advanced Cognitive Stimulation Therapy Hong Kong
Treatment as usualNo interventionStandard care in care homes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment (feasibility of ACST-HK)

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

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

  2. Retention rate (feasibility of ACST-HK)

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

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

  3. Negative of adverse events (acceptability of ACST-HK)

    Any negative or adverse events related to the intervention

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

  4. Intervention fidelity (acceptability of ACST-HK)

    Facilitator's completion of the fidelity checklist following each session

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

  5. Intervention fidelity (acceptability of ACST-HK)

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

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

Secondary outcomes (6)

  1. Change in cognitive function

    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.

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

  2. Change in quality of life

    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.

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

  3. Change in behaviour

    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.

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

  4. Change in engagement

    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.

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

  5. Change in overall well-being

    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.

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

  6. Change in communication abilities

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start1 Nov 2020 (estimated)
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555629
Sponsor's protocol ID
EA2006026
Status last verified
Sep 2020
First submitted
10 Sep 2020
Last updated
21 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 12021425

  • 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.

    PubMed 1634695

  • 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.

    PubMed 9153155

  • 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.

    PubMed 10648298

  • 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.

    PubMed 28214783

  • 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.

    PubMed 16136845

  • 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.

    PubMed 11536346

  • 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).

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

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Cognitive Stimulation Therapy Hong Kong in people with Dementia and Dementia, Vascular, run by University College, London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esther K Hui, BSc (+85264643261, esther.hui.19@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (feasibility of ACST-HK) (time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555629, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.

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