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

Yen Ying Lim; Darshini Ayton; Stephanie Perin; Alexandra Lavale; Nawaf Yassi; Rachel Buckley; Christopher Barton; Loren Bruns; Renata Morello; Stephanie Pirotta; Emily Rosenich; Shantha M W Rajaratnam; Richard Sinnott; Amy Brodtmann; Ashley I Bush; Paul Maruff; Leonid Churilov; Anna Barker; Matthew P Pase; BetterBrains Research Group

doi:10.3233/JAD-210589

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

J Alzheimers Dis. 2021;83(4):1603-1622. doi: 10.3233/JAD-210589.

Authors

Yen Ying Lim¹, Darshini Ayton², Stephanie Perin¹, Alexandra Lavale¹, Nawaf Yassi^{3

4}, Rachel Buckley^{5

6

7

8}, Christopher Barton⁹, Loren Bruns¹⁰, Renata Morello², Stephanie Pirotta², Emily Rosenich¹, Shantha M W Rajaratnam¹, Richard Sinnott¹⁰, Amy Brodtmann⁵, Ashley I Bush⁵, Paul Maruff^{5

11}, Leonid Churilov¹², Anna Barker², Matthew P Pase^{1

13}; BetterBrains Research Group

Affiliations

¹ Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, VIC, Australia.
² Health and Social Care Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
³ Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.
⁴ Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia.
⁵ Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, VIC, Australia.
⁶ Melbourne School of Psychological Sciences, University of Melbourne, Parkville, VIC Australia.
⁷ Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
⁸ Center for Alzheimer Research and Treatment, Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.
⁹ Department of General Practice, School of Primary and Allied Health Care, Monash University, Clayton, VIC, Australia.
¹⁰ School of Computing and Information Systems, University of Melbourne, Parkville, VIC, Australia.
¹¹ Cogstate Ltd., Melbourne, VIC, Australia.
¹² Melbourne Medical School, University of Melbourne, Parkville, VIC, Australia.
¹³ Harvard T.H. Chan School of Public Health, Boston, MA, USA.

PMID: 34420970
DOI: 10.3233/JAD-210589

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.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Behavior Therapy*
Cognitive Dysfunction / prevention & control*
Female
Healthy Volunteers
Humans
Independent Living
Internet
Male
Mental Health
Middle Aged
Prospective Studies
Risk Factors
Risk Reduction Behavior*
Telemedicine*

Associated data

ANZCTR/ACTRN 12621000458831

Grants and funding

K99 AG061238/AG/NIA NIH HHS/United States