Skip to content

BrainLive Connect: Non-professional Delivered CST for People Living With Dementia

BrainLive Connect: Non-professional Delivered Cognitive Stimulation Therapy for People Living With Dementia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07531589
Enrollment
520
Registered
2026-04-15
Start date
2026-03-31
Completion date
2027-11-10
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Dementia, Cognitive Stimulation Therapy, Volunteer-led intervention, Quality of life, Cognitive function, BrainLive Connect, Care burden

Brief summary

The goal of this mixed method study is to evaluate whether the volunteer-led Cognitive Stimulation Therapy (CST) under the BrainLive Connect programme is effective for improving cognitive function and quality of life of people living with dementia (PLwD). The main question it aims to answer are: • Do PLwD receiving the BrainLive Connect service show better cognitive function and quality of life than those receiving usual care? Researchers will compare BrainLive Connect service to usual care to see whether the intervention leads to better outcomes. Participants will: * Receive either 7 weeks of BrainLive Connect sessions delivered by trained volunteers or continue receiving usual care. * Be assessed at baseline (T0), post-intervention (7 weeks; T1), and 1 month follow up (11 weeks; T2). * Take part in semi-strucutred interviews post-intervention to provide feedback on implementation and areas for improvement.

Detailed description

The research design is a non-randomized controlled trial (nRCT), involving 260 PLwD in the experimental group (BrainLive group) who will receive 7 weeks of BrainLive Connect service, and another 260 PLwD in the control group (Care-as-usual group) who will receive usual care for comparison. Participants of the experimental group will be recruited by our partnering NGOs, and those of the control group will be from both the partnering NGOs and network of HKU. Outcomes of PLwD and their carers will be measured at three time points: intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2), to assess the lasting effects of the volunteer-led CST. During the evaluation period, participants in the control group will receive standard care and support. The BrainLive Connect service aimed at maintaining cognitive functions, and improving quality of life (Primary outcomes); and reducing distressed behaviour, improving social functioning, reduced carer burden, improving daily functioning, and preference for ageing-in-place (Secondary outcomes).

Interventions

CST has been recognized as an effective and cost-effective intervention for individuals with mild to moderate dementia, leading to improvements in cognition and quality of life. CST is one of the few non-pharmacological interventions recommended by the National Institute for Health and Care Excellence (NICE) in their clinical guideline on dementia, as it has comparable efficacy to anti-dementia drugs. Exercise-enhanced CST is characterised by adding physical exercise into the original group CST protocol. Home2Community CST is characterized by a gradual shift of its intervention site from the participant's home to public space in their neighbourhood and then further to centre-based settings. Living CST is characterised by transferring CST into real life settings to maximise its benefits in daily functioning for independent living.

OTHERUsual Care

Usual care and support service for people living with dementia in community, including but not limited to, care service, psychosocial intervention (but not CST), and social activities.

Sponsors

The University of Hong Kong
Lead SponsorOTHER
Simon K.Y.Lee Foundation
CollaboratorUNKNOWN
Yang Memorial Methodist Social Service
CollaboratorOTHER
Christian Family Service Centre
CollaboratorOTHER
Hong Kong Young Women's Christian Association
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

PLwD: Hong Kong residents, mild to moderate dementia, either having i) a formal diagnosis, or 2) suspected dementia reported by care professionals and screened by Montreal Cognitive Assessment (MoCA). Family carers: self-identified as the primary carer of the PLwD.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 -70, with higher scores indicate more impairment
Quality of Life-Alzheimer's Disease (QoL-AD)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 13 - 52, with higher scores indicate better quality of life

Secondary

MeasureTime frameDescription
Neuropsychiatric Inventory Questionnaire (NPIQ)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 - 60, with higher scores indicate higher carer distress and severity
Social functioning in Dementia Scale (HKSF-DEM: carer rating)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 - 51, with higher scores indicate better social functioning
Care burden (Zarit Burden Interview short version, 12-item)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 - 48, with higher scores indicate greater burden
The Lawton Instrumental Activities of Daily Living (IADL)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 - 27, with higher scores indicate higher functional independence
Preference for ageing-in place (self-developed scale)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 1 - 5, with higher scores indicate lower preference for ageing-in place
Preparation of ageing in-place (self-developed scale)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 5 - 25, with higher scores indicate better preparation of ageing in place
The Montreal Cognitive Assessment subscale (MoCA subscale)Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)Possible range: 0 - 3, with higher scores indicate better language ability

Countries

Hong Kong

Contacts

CONTACTJACKY CP CHOY, PhD
cpchoy@hku.hk+852 39170079
CONTACTShiyu LU, PhD
sylu@hku.hk+852 39172074
PRINCIPAL_INVESTIGATORShiyu LU

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026