Brain Health Support Program (CTU: BHSP)

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Mild Cognitive Impairment; Dementia Prevention; Subjective Cognitive Impairment
• Intervention / Treatment: Other: Brain Health PRO

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • University of British Columbia
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5A3
      • University of New Brunswick
  • Nova Scotia
    • Cape Breton, Nova Scotia, Canada, B1M 1A2
      • Cape Breton University
  • Ontario
    • London, Ontario, Canada, N6C 5J1
      • Cognitive Clinical Research Group, Parkwood Research Institute
    • London, Ontario, Canada, N6C 5J1
      • Gait and Brain Laboratory, Parkwood Research Institute
    • Toronto, Ontario, Canada, M6A 2E1
      • Baycrest
  • Quebec
    • Montréal, Quebec, Canada, H3W 1W5
      • CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Completion and documentation of the electronic Informed Consent Process (from the participant)
2. Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
3. 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)
4. Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
5. Ability to sit comfortably for a period of about 30 minutes
6. Ages 60-85

7. 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)

8. 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)

9. 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

Exclusion Criteria:

1. 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.
2. Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
3. Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
4. 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
5. Individuals who have a clinical diagnosis of Dementia
6. Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1
7. Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Brain Health PRO	Other: Brain Health PRO; 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.; Other Names: BHPro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-efficacy From Baseline to Month 12	Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE). The GSE measures perceived competence in dealing with a range of stressful or challenging situations. This self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). The total score is the sum of the scores for the 10 items, which is quantitative and ranges from 10-40, with a higher score indicating more self-efficacy. To aide interpretation, change in GSE scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -7.39 to +7.39. The greater the change in score, the greater the increase in self-efficacy.	12 months
To Evaluate Usability of BHPro	Based on System Usability Scale (SUS). The SUS is an 11-item questionnaire with 5-point Likert scale. The total raw score ranges from 0-43 with a higher score indicating greater usability and satisfaction with Brain Health Pro.	12 months
Number of Chapters Completed on BHPro	To evaluate engagement with Brain Health PRO, the number of chapters completed on BHPro was calculated. There is a total of 180 chapters (181 when orientation chapter is included) that are available on BHPro. The program allows participants to view 160 chapters (excluding the orientation chapter) when reaching week 45 (the intended length of the BHPro program). After 45 weeks, the remaining chapters that were still locked will become accessible for users interested in viewing all the program content. The range of chapters that could be completed on Brain Health PRo by participants is 1-181, with a higher number indicating higher engagement with the program.	12 months
To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).	Based on Technology Acceptance Model Questionnaire. The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro.	12 months

Collaborators and Investigators

• Sponsor: Baycrest

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: CTU: BHSP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No