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 - 21/11/24

Doi : 10.14283/jpad.2023.65 
Howard H. Feldman 1, 2, , S. Belleville 3, 4, H.B. Nygaard 5, M. Montero-Odasso 6, 7, J. Durant 1, 2, J.-L. Lupo 1, 2, C. Revta 1, 2, S. Chan 8, M. Cuesta 3, P.J. Slack 5, S. Winer 9, P.W.H. Brewster 9, S.M. Hofer 9, A. Lim 10, A. Centen 10, D.M. Jacobs 1, 2, N.D. Anderson 8, J.D. Walker 11, M.R. Speechley 12, G.Y. Zou 12, H. Chertkow 8

Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group

1 Department of Neurosciences, University of California San Diego, 9500 Gilman Drive, MC 0949, 92037-0949, La Jolla, California, USA 
2 Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, USA 
3 Centre de recherche de l’Institut Universitaire de gériatrie du CIUSSS du Centre-Sud-de-l’Île-de-Montréal, Montreal, Quebec, Canada 
4 Université de Montréal, Montreal, Quebec, Canada 
5 Division of Neurology, University of British Columbia, Vancouver, British Columbia, Canada 
6 Gait and Brain Laboratory, Lawson Health Research Institute, Parkwood Institute, London, Ontario, Canada 
7 Schulich School of Medicine and Dentistry, Department of Medicine (Geriatrics), University of Western Ontario, London, Ontario, Canada 
8 Rotman Research Institute and Baycrest Health Sciences, University of Toronto, Toronto, Ontario, Canada 
9 Cognition & Technology Research Group, Institute on Aging and Lifelong Health, University of Victoria, Victoria, British Columbia, Canada 
10 Sunnybrook Research Institute, Toronto, Ontario, Canada 
11 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada 
12 Schulich School of Medicine and Dentistry, Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada 

a howardfeldman@health.ucsd.edu howardfeldman@health.ucsd.edu

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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).

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Key words : Alzheimer’s disease, dementia, prevention, Brain Health PRO, NCT05347966


Plan


 Trial registration: NCT05347966.


© 2023  THE AUTHORS. Published by Elsevier Masson SAS on behalf of SERDI Publisher.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 10 - N° 4

P. 875-885 - novembre 2023 Retour au numéro
Article précédent Article précédent
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