Brain Health Support Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment, Cognitive Change

Intervention / Treatment
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* Other: Brain Health PRO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Brain Health PRO<br> | Other: Brain Health PRO<br>* 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.<br>* Other names: BHPro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia Literacy | The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE). | 12 months | 
| To evaluate usability of BHPro | Based on System Usability Scale | 12 months | 
| To evaluate Engagement of BHPro | Number of chapters completed on BHPro | 12 months | 
| To evaluate user acceptance of BHPro | Based on Technology Acceptance Model Questionnaire | 12 months |