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

April 15, 2026 updated by: Choy Chak Pui Jacky, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shiyu LU, PhD
  • Phone Number: +852 39172074
  • Email: sylu@hku.hk

Study Contact Backup

  • Name: JACKY CP CHOY, PhD
  • Phone Number: +852 39170079
  • Email: cpchoy@hku.hk

Study Locations

  • Hong Kong
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual social care
Participants will receive usual social care and support provided by elderly care service units operated by non-governmental organisations, including but not limited to care services, psychosocial intervention, and social activites.
Other: Usual 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.
Experimental: Non-professional delivered CST
Participants will receive 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers, with two sessions per week over a period of 7 weeks
Behavioral: Cognitive Stimulation Therapy (CST)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Quality of Life-Alzheimer's Disease (QoL-AD)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory Questionnaire (NPIQ)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Social functioning in Dementia Scale (HKSF-DEM: carer rating)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Care burden (Zarit Burden Interview short version, 12-item)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Lawton Instrumental Activities of Daily Living (IADL)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preference for ageing-in place (self-developed scale)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preparation of ageing in-place (self-developed scale)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Montreal Cognitive Assessment subscale (MoCA subscale)
Time Frame: 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
Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hong Kong Young Women's Christian Association
Christian Family Service Centre
Simon K.Y.Lee Foundation
Yang Memorial Methodist Social Service

Investigators

  • Principal Investigator: Shiyu LU, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

November 10, 2027

Study Completion (Estimated)

November 10, 2027

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA250765a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data will be available upon request.

IPD Sharing Time Frame

Anonymised data data will be available after the first manuscript using the study data is published.

IPD Sharing Access Criteria

Anonymised data will be available upon request.

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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