NCT07544875

Brief Summary

The goal of this mixed method clinical trial is to evaluate whether BrainLive Coach training can enhance knowledge, skills, and wellbeing among young old volunteers. The main question it aims to answer are:

  • Participate in either 80-90 hours of BrainLive Coach training followed by volunteering in BrainLive Connect or receive educational materials on dementia and cognitive health.
  • Complete assessments at baseline (T0) and post intervention (T1) on dementia knowledge, competence in dementia care, self-efficacy, attitudes to dementia, quality of life, and social capital.
  • Qualitative study participants • Take part in individual interviews or focus groups, including trained volunteers, and NGO staff, to explore perceived impacts, mechanisms, implementation facilitators/barriers, and areas for improvement.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress13%
Feb 2026Nov 2027

Study Start

First participant enrolled

February 13, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 8, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

DementiaCognitive Stimulation TherapyVolunteer-led interventionYoung-old volunteersBrainLive ConnectSense of competence

Outcome Measures

Primary Outcomes (3)

  • Dementia Knowledge Assessment Tool (DKAT)

    Possible range: 0 - 21, with higher scores indicate better knowledge

    Baseline (T0) and 3 months after start of CST training (T1)

  • Sense of Competence in Dementia Care (SCIDC)

    Possible range: 17 - 68, with higher scores indicate better sense of competence in dementia care

    Baseline (T0) and 3 months after start of CST training (T1)

  • Approaches to Dementia Questionnaire (ADQ)

    Possible range: 19 - 95, with higher scores indicate more positive and person-centered attitude

    Baseline (T0) and 3 months after start of CST training (T1)

Secondary Outcomes (8)

  • The Lubben Social Network Scale-6 (LSNS-6)

    Baseline (T0) and 3 months after start of CST training (T1)

  • QoL: 8-item WHO quality of life scale

    Baseline (T0) and 3 months after start of CST training (T1)

  • The General Self-Efficacy Scale

    Baseline (T0) and 3 months after start of CST training (T1)

  • Bidirectional Social Support (2-Way SSS)

    Baseline (T0) and 3 months after start of CST training (T1)

  • Sense of belonging

    Baseline (T0) and 3 months after start of CST training (T1)

  • +3 more secondary outcomes

Study Arms (2)

Cognitive Stimulation Therapy (CST) trained volunteers

EXPERIMENTAL

Intervention group volunteers receive comprehensive CST training

Behavioral: BrainLive Coach training

Non-cognitive stimulation therapy trained volunteers

ACTIVE COMPARATOR

Control group volunteers receive dementia-related educational materials

Other: Other intervention

Interventions

Volunteers will be trained, supervised and supported to deliver one of three modes of CST (Exercise-enhanced CST, Home2Community CST, Living CST). Basic level training covering topics fundamental to dementia education and common across different CST modes to all recruited volunteers; and then advanced level training covering knowledge and skills specific to each CST mode and service settings.

Cognitive Stimulation Therapy (CST) trained volunteers

Volunteers will receive dementia-related educational materials

Non-cognitive stimulation therapy trained volunteers

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hong Kong residents
  • Aged 50 and over
  • Had education level of Form 3 or above
  • Fluent in Cantonese
  • Able to read and write Chinese

You may not qualify if:

  • Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (7)

  • Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.

    PMID: 26607411BACKGROUND
  • Knapp M, Bauer A, Wittenberg R, Comas-Herrera A, Cyhlarova E, Hu B, Jagger C, Kingston A, Patel A, Spector A, Wessel A, Wong G. What are the current and projected future cost and health-related quality of life implications of scaling up cognitive stimulation therapy? Int J Geriatr Psychiatry. 2022 Jan;37(1). doi: 10.1002/gps.5633. Epub 2021 Oct 15.

    PMID: 34613622BACKGROUND
  • 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.

    PMID: 16738349BACKGROUND
  • 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/

    PMID: 30011160BACKGROUND
  • Ryan S, Brady O. Cognitive stimulation and activities of daily living for individuals with mild-to-moderate dementia: A scoping review. Br J Occup Ther. 2023 Aug;86(8):540-559. doi: 10.1177/03080226231156517. Epub 2023 Mar 15.

    PMID: 40337614BACKGROUND
  • Toh HM, Ghazali SE, Subramaniam P. The Acceptability and Usefulness of Cognitive Stimulation Therapy for Older Adults with Dementia: A Narrative Review. Int J Alzheimers Dis. 2016;2016:5131570. doi: 10.1155/2016/5131570. Epub 2016 Jul 11.

    PMID: 27478677BACKGROUND
  • Desai R, Leung WG, Fearn C, John A, Stott J, Spector A. Effectiveness of Cognitive Stimulation Therapy (CST) for mild to moderate dementia: A systematic literature review and meta-analysis of randomised control trials using the original CST protocol. Ageing Res Rev. 2024 Jun;97:102312. doi: 10.1016/j.arr.2024.102312. Epub 2024 Apr 16.

    PMID: 38636561BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shiyu LU, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JACKY CP CHOY, PhD

CONTACT

Shiyu LU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The BrainLive Connect Model will be delivered by trained "young-old" volunteers, whom the investigators refer to as BrainLive Volunteers. Their participation enhances the delivery of the model and fosters social connections and promotes active ageing among the volunteers themselves. Volunteers will be trained, supervised and supported to deliver CST. Basic level training will cover topics fundamental to dementia education and common across different CST modes for all recruited volunteers, followed by advanced level training covering knowledge and skills specific to each CST mode and service settings.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 22, 2026

Study Start

February 13, 2026

Primary Completion (Estimated)

November 10, 2027

Study Completion (Estimated)

November 10, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymised data will be available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Anonymised data will be available after the first manuscript using the study data is published.
Access Criteria
Anonymised data will be available upon request.

Locations