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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Dementia

Treatments: Other: Usual Care; Behavioral: Cognitive Stimulation Therapy (CST)

Study type: Interventional

Funder types: Other

Identifiers

NCT07531589

EA250765a

Details and patient eligibility

About

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.

Full 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).

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups

Non-professional delivered CST

Experimental group

Description:

Participants will receive 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers, with two sessions per week over a period of 7 weeks

Treatment:

Behavioral: Cognitive Stimulation Therapy (CST)

Usual social care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care