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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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
• Другое 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.

Первичные конечные точки

• The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [Срок оценки: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)]
• Quality of Life-Alzheimer's Disease (QoL-AD) [Срок оценки: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong — Гонконг

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07531589 · EA250765a

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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