An Online, Person-Centered, Risk Factor Management Program to Prevent Cognitive Decline: Protocol for A Prospective Behavior-Modification Blinded Endpoint Randomized Controlled Trial

Article type: Research Article

Authors: Lim, Yen Ying^{a; *} | Ayton, Darshini^b | Perin, Stephanie^a | Lavale, Alexandra^a | Yassi, Nawaf^{c; d} | Buckley, Rachel^{e; f; g; h} | Barton, Christopherⁱ | Bruns Jr, Loren^j | Morello, Renata^b | Pirotta, Stephanie^b | Rosenich, Emily^a | Rajaratnam, Shantha M.W.^a | Sinnott, Richard^j | Brodtmann, Amy^e | Bush, Ashley I.^e | Maruff , Paul^{e; l} | Churilov, Leonid^k | Barker, Anna^b | Pase, Matthew P.^{a; m} | on behalf of the BetterBrains Research Group

Affiliations: [a] Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, VIC, Australia | [b] Health and Social Care Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia | [c] Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia | [d] Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia | [e] Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, VIC, Australia | [f] Melbourne School of Psychological Sciences, University of Melbourne, Parkville, VIC Australia | [g] Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA | [h] Center for Alzheimer Research and Treatment, Department of Neurology, Brigham and Women’s Hospital, Boston, MA, USA | [i] Department of General Practice, School of Primary and Allied Health Care, Monash University, Clayton, VIC, Australia | [j] School of Computing and Information Systems, University of Melbourne, Parkville, VIC, Australia | [k] Melbourne Medical School, University of Melbourne, Parkville, VIC, Australia | [l] Cogstate Ltd., Melbourne, VIC, Australia | [m] Harvard T.H. Chan School of Public Health, Boston, MA, USA

Correspondence: [*] Correspondence to: Yen Ying Lim, Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Level 6, 18 Innovation Walk, Clayton, VIC 3168, Australia. E-mail: [email protected].

Abstract: Background:Several modifiable risk factors for dementia have been identified, although the extent to which their modification leads to improved cognitive outcomes remains unclear. Objective:The primary aim is to test the hypothesis that a behavior modification intervention program targeting personalized risk factors prevents cognitive decline in community-dwelling, middle-aged adults with a family history of dementia. Methods:This is a prospective, risk factor management, blinded endpoint, randomized, controlled trial, where 1510 cognitively normal, community-dwelling adults aged 40–70 years old will be recruited. Participants will be screened for risk factors related to vascular health (including physical inactivity), mental health, sleep, and cognitive/social engagement. The intervention is an online person-centered risk factor management program: BetterBrains. Participants randomized to intervention will receive telehealth-based person-centered goal setting, motivational interviewing, and follow-up support, health care provider communication and community linkage for management of known modifiable risk factors of dementia. Psychoeducational health information will be provided to both control and intervention groups. Results:The primary outcome is favorable cognitive performance at 24-months post-baseline, defined as the absence of decline on one or more of the following cognitive tests: (a) Cogstate Detection, (b) Cogstate One Card Learning, (c) Cogstate One Back, and (d) Cognitive Function Instrument total score. Conclusion:We will test the hypothesis that the BetterBrains intervention program can prevent cognitive decline. By leveraging existing community services and using a risk factor management pathway that tailors the intervention to each participant, we maximize likelihood for engagement, long-term adherence, and for preserving cognitive function in at-risk individuals.

Keywords: Alzheimer’s disease, clinical trial, cognitive decline, dementia, lifestyle intervention, non-pharmacological, randomized control trial

DOI: 10.3233/JAD-210589

Journal: Journal of Alzheimer's Disease, vol. 83, no. 4, pp. 1603-1622, 2021