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NCT Number: NCT07531589

BrainLive Connect: Non-professional Delivered CST 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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

JACKY CP CHOY, Philosophy of Doctor

CONTACT

[email protected]

39170079

Shiyu LU, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

JACKY CP CHOY, PhD

CONTACT

[email protected]

+852 39170079

Shiyu LU, PhD

CONTACT

[email protected]

+852 39172074

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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