Brain Health Support Program

NCT05347966 | Completed Results

• 1 other identifier: CTU: BHSP
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 7

Brief Summary

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP, or CTU) is a comprehensive and innovative program aimed to develop, implement and evaluate an interactive and compelling online educational Brain Health Support Program (BHSP) intervention, called Brain Health PRO (BHPro), with potential to positively influence dementia literacy, lifestyle risk factors, and scale-up to reach the broader Canadian public; enroll and retain a community-dwelling Platform Trial Cohort (PTC) of individuals at risk of dementia; and support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia.

Conditions

Dementia Prevention; Mild Cognitive Impairment; Subjective Cognitive Impairment; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• Change in Dementia Literacy From Baseline to Month 12

  The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is designed to assess knowledge about Alzheimer's Disease (AD) among laypeople, patients, caregivers, and professionals. This self-report questionnaire contains 30 true/false items. The total score is the sum of the scores from the 30 items, which is quantitative and ranges from 0-30, with a higher score indicating better knowledge about AD. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia.

  12 months

Secondary Outcomes (4)

• Change in Self-efficacy From Baseline to Month 12

  12 months

• To Evaluate Usability of BHPro

  12 months

• Number of Chapters Completed on BHPro

  12 months

• To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).

  12 months

Study Arms (1)

Brain Health PRO

OTHER

Other: Brain Health PRO

Interventions

Brain Health PRO OTHER

BHPro is a 45-week, multidomain web-based formal educational program which has been designed to increase dementia literacy, convey best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health.

Also known as: BHPro

Brain Health PRO

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion and documentation of the electronic Informed Consent Process (from the participant)
• Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
• Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)
• Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
• Ability to sit comfortably for a period of about 30 minutes
• Ages 60-85
• Meets criteria for No Dementia and meet criteria \[according to Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1\] of one of the following:
• Cognitively Unimpaired (CU)
• Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI)
• Mild Cognitive Impairment (MCI)
• AND Classified as being at increased risk of dementia based on at least one of the following:
• First-degree family history of dementia
• Self-Reported or documented current and/or history at midlife (45-60 years) on any of the following lifestyle risk factors:
• Hypertension (documented Systolic Blood Pressure \> 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise)) Hypercholesterolemia (documented total cholesterol \> 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise) Body Mass Index \> 30 kg/m2 (derived from NIH Metric BMI Calculator) Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
• Participant has a family physician or other healthcare provider and agrees to have the provider notified of participation in the study and incidental or other findings that may be clinically significant

You may not qualify if:

• Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.
• Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
• Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
• Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments
• Individuals who have a clinical diagnosis of Dementia
• Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of \>1
• Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) \<13

Sponsors & Collaborators

• Baycrest: lead

Study Sites (7)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

University of New Brunswick

Fredericton, New Brunswick, E3B 5A3, Canada

Location

Cape Breton University

Cape Breton, Nova Scotia, B1M 1A2, Canada

Location

Cognitive Clinical Research Group, Parkwood Research Institute

London, Ontario, N6C 5J1, Canada

Location

Gait and Brain Laboratory, Parkwood Research Institute

London, Ontario, N6C 5J1, Canada

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, H3W 1W5, Canada

Location

Related Publications (2)

• Belleville S, Anderson ND, Bherer L, Camicioli R, Carrier J, Chan S, Cuesta M, Dang-Vu TT, Dwosh E, Fiocco AJ, Ferland G, Gilbert B, Harris E, Itzhak I, Jarrett P, Kadri MA, Laurin D, Liu-Ambrose T, McGibbon CA, Middleton L, Miller L, Nygaard HB, Montero-Odasso M, Murphy K, Phillips N, Pichora-Fuller MK, Robillard JM, Smith EE, Speechley M, Trigui A, Wittich W, Chertkow H, Feldman HH; CTU expert group for the Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Brain health PRO/Sante cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction. J Prev Alzheimers Dis. 2025 Jun;12(6):100134. doi: 10.1016/j.tjpad.2025.100134. Epub 2025 Mar 15.

  PMID: 40090784 DERIVED

• 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, Chertkow H. 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. J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65.

  PMID: 37874110 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Haakon Nygaard
• Organization: UBC

haakon.nygaard@ubc.ca

604-827-0600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 27, 2022
• Study Start: April 6, 2022
• Primary Completion: January 5, 2024
• Study Completion: April 19, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Locations

CA (7)