1. Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study.
- Author
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Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, Durant J, Lupo JL, Revta C, Chan S, Cuesta M, Slack PJ, Winer S, Brewster PWH, Hofer SM, Lim A, Centen A, Jacobs DM, Anderson ND, Walker JD, Speechley MR, Zou GY, and Chertkow H
- Subjects
- Aged, Humans, Canada, Longitudinal Studies, Prospective Studies, Alzheimer Disease, Brain
- Abstract
Background/objectives: CAN-THUMBS UP is designed as a comprehensive and innovative fully remote program to 1) develop an interactive and compelling online Brain Health Support Program intervention, with potential to positively influence dementia literacy, self-efficacy and lifestyle risk factors; 2) enroll and retain a community-dwelling Platform Trial Cohort of individuals at risk of dementia who will participate in the intervention; 3) support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia. This manuscript presents the Brain Health Support Program Study protocol., Design/setting: Twelve-month prospective multi-center longitudinal study to evaluate a fully remote web-based educational intervention. Participants will subsequently be part of a Platform Trial Cohort and may be eligible to participate in further dementia prevention clinical trials., Participants: Three hundred fifty older adults who are cognitively unimpaired or have mild cognitive impairment, with at least 1 well established dementia risk factor., Intervention: Participants engage in the Brain Health Support Program intervention for 45-weeks and complete pre/post intervention measures. This intervention is designed to convey best available evidence for dementia prevention, consists of 181 chapters within 8 modules that are progressively delivered, and is available online in English and French. The program has been developed as a collaborative effort by investigators with recognized expertise in the program's content areas, along with input from older-adult citizen advisors., Measurements: This study utilizes adapted remote assessments with accessible technologies (e.g. videoconferencing, cognitive testing via computer and mobile phone, wearable devices to track physical activity and sleep, self-administered saliva sample collection). The primary outcome is change in dementia literacy, as measured by the Alzheimer's Disease Knowledge Scale. Secondary outcomes include change in self-efficacy; engagement using the online program; user satisfaction ratings; and evaluation of usability and acceptance. Exploratory outcomes include changes in attitudes toward dementia, modifiable risk factors, performance on the Neuropsychological Test Battery, performance on self-administered online cognitive assessments, and levels of physical activity and sleep; success of the national recruitment plan; and the distribution of age adjusted polygenic hazard scores., Conclusions: This fully remote study provides an accessible approach to research with all study activities being completed in the participants' home environment. This approach may reduce barriers to participation, provide an easier and less demanding participant experience, and reach a broader geography with recruitment from all regions of Canada. CAN-THUMBS UP represents a Canadian contribution to the global World-Wide FINGERS program (alz.org/wwfingers)., Competing Interests: HF reports grant funding from CIHR to the CCNA (CNA-163902) that supported this study. Outside of this study, he also reports grant funding from Annovis (QR Pharma), Vivoryon (Probiodrug), AC Immune, and LuMind; service agreements for consulting activities with LuMind, Genentech (DSMB), Roche/Banner (DMC), Tau Consortium (SAB), Samus Therapeutics, Biosplice Therapeutics, Axon Neurosciences, Novo Nordisk Inc., Janssen Research and Development LLC; and travel funding from World Events Forum (ADDF) with no personal funds received and all payments to UCSD. He also reports a philanthropic donation from the Epstein Family Alzheimer’s Disease Collaboration for therapeutic research in AD with no personal funds received and all payments to UCSD. SB reports grant funding to CCNA from CIHR and ASC that supported this study. Outside of this study, she also reports consulting fees and participation on an advisory board for Lucilab and an unpaid role of scientific advisor for the Quebec Federation of Alzheimer’s Societies. HN reports consulting fees from Hoffman-La Roche and Biogen. AL reports a Centre for Aging Brain Health Innovation Grant (CCNA-1-00295) that helped support this study. NA reports grants from CIHR, Social Sciences and Humanities Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Centre for Aging + Brain Health Innovation, Canadian Foundation for Innovation, Fonds de Recherché Société et Culture Québec, and ASC. She also reports book royalties from Oxford University Press and consulting fees from the National Eye Institute. JW reports grant funding to her institution from AGE-WELL and MIRI (McMaster Institute for Research in Aging) to support a postdoctoral fellowship and CIHR funding to CCNA Team 18 to support Indigenous research in the CCNA. She also reports unpaid roles as a member of the Federal Ministerial Advisory Committee on Dementia and the Medical and Scientific Advisory Board for Alzheimer’s Disease International. MS reports unpaid roles as a member of the Data Safety and Monitoring Board (DSMB) for Intervention in Parkinson’s Disease and the Chair of the DSMB for Intervention in Depression. As Scientific Director of CCNA, HC reports grants from CIHR, Baycrest Health Sciences Foundation, Women’s Brain Health Initiative, Alzheimer Society of Canada, Brain Canada, Saskatchewan Health Research Foundation, Alberta Innovates, and Weston Foundation (Weston Brain Institute). As a site investigator for clinical trials, he also receives support from Roche, Lilly, Anavex, and Alector. He reports being a member of the Ministerial Advisory Board on Dementia (2019-2022) and part of the membership organizing committee for Canadian Conference on Dementia.
- Published
- 2023
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