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

NCT07531589 | Recruiting

• 1 other identifier: EA250765a
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  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)

  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 Outcomes (7)

• Neuropsychiatric Inventory Questionnaire (NPIQ)

  Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

• Social functioning in Dementia Scale (HKSF-DEM: carer rating)

  Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

• Care burden (Zarit Burden Interview short version, 12-item)

  Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

• The Lawton Instrumental Activities of Daily Living (IADL)

  Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

• Preference for ageing-in place (self-developed scale)

  Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)

Study Arms (2)

Non-professional delivered CST

EXPERIMENTAL

Participants will received 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers; two sessions per week; for 7 weeks

Behavioral: Cognitive Stimulation Therapy (CST)

Usual social care

ACTIVE COMPARATOR

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

Interventions

Cognitive Stimulation Therapy (CST) BEHAVIORAL

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.

Non-professional delivered CST

Usual Care OTHER

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.

Usual social care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Simon K.Y.Lee Foundation: collaborator
• Yang Memorial Methodist Social Service: collaborator
• Christian Family Service Centre: collaborator
• Hong Kong Young Women's Christian Association: collaborator

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: 26607411 BACKGROUND

• 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: 34613622 BACKGROUND

• 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: 16738349 BACKGROUND

• 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: 30011160 BACKGROUND

• 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: 40337614 BACKGROUND

• 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: 27478677 BACKGROUND

• 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: 38636561 BACKGROUND

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

JACKY C.P. CHOY, PhD

CONTACT

+852 39170079; cpchoy@hku.hk

Shiyu LU, PhD

CONTACT

+852 39172074; sylu@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

HK (1)