Healthy Adults Aged 50 and OverNCT07544875
BrainLive Connect: Volunteer Training Programme
A study testing BrainLive Coach training and Other intervention in people with Healthy Adults Aged 50 and Over, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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: Do trained BrainLive Coaches demonstrate greater CST-related knowledge/skills, self-efficacy, and improved… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults Aged 50 and Over
- What is being tested?
- BrainLive Coach training and Other intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Feb 2026to 10 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong residents
- Aged 50 and over
- Had education level of Form 3 or above
- Fluent in Cantonese
- Able to read and write Chinese
Who cannot join
- Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
JACKY CP CHOY, Philosophy of Doctor, 39170079, cpchoy@hku.hk
Shiyu LU, PhD
About this study
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:
Read more
- Do trained BrainLive Coaches demonstrate greater CST-related knowledge/skills, self-efficacy, and improved quality of life compared with volunteers receiving only educational materials?
Researchers will compare the BrainLive Coach training group vs. general service group (young old volunteers) to see whether the intervention leads to enhanced dementia knowledge, sense of competence in dementia care, and approaches to dementia.
Participants will be:
- Adults aged 50 and over - volunteers (nRCT)
- 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.
Read the detailed description
The research design is a non-randomized controlled trial (nRCT), involving 90 healthy adults aged 50 and over in the experimental group (Training group) who will receive 80-90 hours of BrainLive Coach Training, and another 90 young-old in the control group (Education group) who will receive educational workshops for comparison. Data will be collected at two time points: baseline (T0) and after the completion of BrainLive Connect volunteering (T1). Participants in the control group (N=90) will be recruited from the HKU network. During the evaluation period, control group participants will attend educational workshops focused on dementia and cognitive health.
The BrainLive Coach training aims to enhance the skills and knowledge for delivering evidence-based dementia intervention (Primary outcomes); and improve self-efficacy, quality of life, and social capital of the young-old individuals. The outcome measures include Dementia Knowledge Assessment Tool, Sense of Competence in Dementia Care, Approaches to Dementia, General Self-efficacy scale, Quality of Life and social capital assessment tool.
- Conditions
- Healthy Adults Aged 50 and Over
- Being tested
- BrainLive Coach training, Other intervention
- Keywords
- Dementia, Cognitive Stimulation Therapy, Volunteer-led intervention, Young-old volunteers, BrainLive Connect, Sense of competence
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainLive Coach trainingBehavioural
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.
Other interventionOther
Volunteers will receive dementia-related educational materials
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulation Therapy (CST) trained volunteers | Experimental | Intervention group volunteers receive comprehensive CST training Receives: Behavioral: BrainLive Coach training |
| Non-cognitive stimulation therapy trained volunteers | Active comparator | Control group volunteers receive dementia-related educational materials Receives: Other: Other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Knowledge Assessment Tool (DKAT)
Possible range: 0 - 21, with higher scores indicate better knowledge
Measured: 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
Measured: 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
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Secondary outcomes (8)
The Lubben Social Network Scale-6 (LSNS-6)
Possible range: 0 - 30, with higher scores indicate greater social support and engagement. A total score of 12 or less is commonly used as a cut-off point to identify individuals at risk for social isolation
Measured: Baseline (T0) and 3 months after start of CST training (T1)
QoL: 8-item WHO quality of life scale
Possible range: 8 - 40, with higher scores indicate better quality of life
Measured: Baseline (T0) and 3 months after start of CST training (T1)
The General Self-Efficacy Scale
Possible range: 10 - 40, with higher scores indicate higher self-efficacy
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Bidirectional Social Support (2-Way SSS)
Possible range: 0 - 60, with higher scores indicate more bidirectional social support
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Sense of belonging
Possible range: 16 - 80, with higher scores indicate better sense of belonging
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Meaning in life
Possible range: 10 - 70, with higher scores indicate better meaning in life
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Well-being
Possible range: 7 - 35, with higher scores indicate better well-being
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Caregiver burden
Possible range: 0 - 48, with higher scores indicate higher caregiver burden
Measured: Baseline (T0) and 3 months after start of CST training (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 Feb 2026
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy Adults Aged 50 and OverStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation, Yang Memorial Methodist Social Service, Christian Family Service Centre, Hong Kong Young Women's Christian Association
- Responsible party
- Principal investigator, Choy Chak Pui Jacky, The University of Hong Kong
- Investigators
- Shiyu LU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544875
- Sponsor's protocol ID
- EA250765b
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be available upon request.
Publications
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.
PubMed 26607411Knapp 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.
PubMed 34613622Knapp 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.
PubMed 16738349Dementia: 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/
PubMed 30011160Ryan 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.
PubMed 40337614Toh 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.
PubMed 27478677Desai 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.
PubMed 38636561
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainLive Connect: Volunteer Training Programme
- ClinicalTrials.gov ID
- NCT07544875
- Acronym / sponsor ID
- EA250765b
- Conditions
- Healthy Adults Aged 50 and Over
- Keywords
- Dementia, Cognitive Stimulation Therapy, Volunteer-led intervention, Young-old volunteers, BrainLive Connect, Sense of competence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation, Yang Memorial Methodist Social Service, Christian Family Service Centre, Hong Kong Young Women's Christian Association
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do trained BrainLive Coaches demonstrate greater CST-related knowledge/skills, self-efficacy, and improved quality of life compared with volunteers receiving only educational materials?
Researchers will compare the BrainLive Coach training group vs. general service group (young old volunteers) to see whether the intervention leads to enhanced dementia knowledge, sense of competence in dementia care, and approaches to dementia.
Participants will be:
- Adults aged 50 and over - volunteers (nRCT)
- 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.
Detailed description
The research design is a non-randomized controlled trial (nRCT), involving 90 healthy adults aged 50 and over in the experimental group (Training group) who will receive 80-90 hours of BrainLive Coach Training, and another 90 young-old in the control group (Education group) who will receive educational workshops for comparison. Data will be collected at two time points: baseline (T0) and after the completion of BrainLive Connect volunteering (T1). Participants in the control group (N=90) will be recruited from the HKU network. During the evaluation period, control group participants will attend educational workshops focused on dementia and cognitive health.
The BrainLive Coach training aims to enhance the skills and knowledge for delivering evidence-based dementia intervention (Primary outcomes); and improve self-efficacy, quality of life, and social capital of the young-old individuals. The outcome measures include Dementia Knowledge Assessment Tool, Sense of Competence in Dementia Care, Approaches to Dementia, General Self-efficacy scale, Quality of Life and social capital assessment tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulation Therapy (CST) trained volunteers | Experimental | Behavioral: BrainLive Coach trainingIntervention group volunteers receive comprehensive CST training |
| Non-cognitive stimulation therapy trained volunteers | Active comparator | Other: Other interventionControl group volunteers receive dementia-related educational materials |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents
- Aged 50 and over
- Had education level of Form 3 or above
- Fluent in Cantonese
- Able to read and write Chinese
Key exclusion criteria (1 listed)
- Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainLive Coach trainingVolunteers 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. | Behavioural | Cognitive Stimulation Therapy (CST) trained volunteers |
| Other interventionVolunteers will receive dementia-related educational materials | Other | Non-cognitive stimulation therapy trained volunteers |
Primary outcome
Dementia Knowledge Assessment Tool (DKAT)
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Possible range: 0 - 21, with higher scores indicate better knowledge
Sense of Competence in Dementia Care (SCIDC)
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Possible range: 17 - 68, with higher scores indicate better sense of competence in dementia care
Approaches to Dementia Questionnaire (ADQ)
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Possible range: 19 - 95, with higher scores indicate more positive and person-centered attitude
8 secondary outcomes
The Lubben Social Network Scale-6 (LSNS-6)
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
QoL: 8-item WHO quality of life scale
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
The General Self-Efficacy Scale
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Bidirectional Social Support (2-Way SSS)
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Sense of belonging
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Meaning in life
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Well-being
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Caregiver burden
Time frame: Baseline (T0) and 3 months after start of CST training (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 26607411Groot 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.
- Background: PubMed 34613622Knapp 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.
- Background: PubMed 16738349Knapp 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.
- Background: PubMed 30011160Dementia: 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/
- Background: PubMed 40337614Ryan 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.
- Background: PubMed 27478677Toh 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.
- Background: PubMed 38636561Desai 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.
- Individual participant dataSharing planned: Yes. Anonymised data will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiyu LU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainLive Coach training and Other intervention in people with Healthy Adults Aged 50 and Over, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JACKY CP CHOY, PhD (39170079, cpchoy@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Knowledge Assessment Tool (DKAT) (time frame: Baseline (T0) and 3 months after start of CST training (T1)). The study lists 3 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 NCT07544875, which also lists 7 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 29 Apr 2026.