- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544875
BrainLive Connect: Volunteer Training Programme
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JACKY CP CHOY, PhD
- Phone Number: 39170079
- Email: cpchoy@hku.hk
Study Contact Backup
- Name: Shiyu LU, PhD
- Phone Number: 39172074
- Email: sylu@hku.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Principal Investigator:
- Shiyu LU, PhD
-
Contact:
- JACKY CP CHOY, Philosophy of Doctor
- Phone Number: 39170079
- Email: cpchoy@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hong Kong residents
- Aged 50 and over
- Had education level of Form 3 or above
- Fluent in Cantonese
- Able to read and write Chinese
Exclusion Criteria:
Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Stimulation Therapy (CST) trained volunteers
Intervention group volunteers receive comprehensive CST training
|
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.
|
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Active Comparator: Non-cognitive stimulation therapy trained volunteers
Control group volunteers receive dementia-related educational materials
|
Volunteers will receive dementia-related educational materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (T0) and 3 months after start of CST training (T1)
|
|
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
|
Baseline (T0) and 3 months after start of CST training (T1)
|
|
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
|
Baseline (T0) and 3 months after start of CST training (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Lubben Social Network Scale-6 (LSNS-6)
Time Frame: Baseline (T0) and 3 months after start of CST training (T1)
|
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
|
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)
|
Possible range: 8 - 40, with higher scores indicate better quality of life
|
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)
|
Possible range: 10 - 40, with higher scores indicate higher self-efficacy
|
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)
|
Possible range: 0 - 60, with higher scores indicate more bidirectional social support
|
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)
|
Possible range: 16 - 80, with higher scores indicate better sense of belonging
|
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)
|
Possible range: 10 - 70, with higher scores indicate better meaning in life
|
Baseline (T0) and 3 months after start of CST training (T1)
|
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Well-being
Time Frame: Baseline (T0) and 3 months after start of CST training (T1)
|
Possible range: 7 - 35, with higher scores indicate better well-being
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Baseline (T0) and 3 months after start of CST training (T1)
|
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Caregiver burden
Time Frame: Baseline (T0) and 3 months after start of CST training (T1)
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Possible range: 0 - 48, with higher scores indicate higher caregiver burden
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Baseline (T0) and 3 months after start of CST training (T1)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shiyu LU, PhD, The University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA250765b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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