The Brain Health PRO Online Risk Factor Reduction Study to Prevent Dementia (BHPROOF)

University of British Columbia

Status: Begins enrollment this month

Conditions: Dementia Education; Cognitive Change; Mild Cognitive Impairment; Lifestyle Intervention; Subjective Cognitive Impairment; Dementia Prevention

Treatments: Other: Brain Health PRO

Study type: Interventional

Funder types: Other

Identifiers

NCT07364019

H25-03523

Details and patient eligibility

About

This study will recruit participants at risk for dementia to participate in an online educational program called Brain Health PRO (BHPro). The BHPro intervention is designed to address modifiable risk factors for dementia through a 6-month, fully online, educational program conveying the best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health. Achieving lifestyle changes in a diverse Canadian population through online education would be a major achievement in dementia prevention in Canada, with widespread personal and socioeconomic benefits.

Eligible participants will be randomly assigned to either start Brain Health PRO immediately or in 6 months (delayed-start control group). All participants will have the opportunity to have access to BHPro for 6 months during the course of the study and will have open access to all content for 12 months following the initial 6-month intervention. Participation will last from 18-24 months depending on group assignment.

Enrollment: 700 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Completion and documentation of the electronic Informed Consent Process (from the participant)

• Sufficient proficiency in English or French to undergo online assessments and participate in an online educational program.

• Technical ability to participate in an online educational program and remote assessments (i.e., regularly have access to a computer or tablet with an internet connection; have access to a desktop or laptop computer with an internet connection at least once every 6 months; ability to send and receive emails; ability to complete online assessments)

• Sufficient vision to participate in an online educational program and complete online cognitive testing

• Ages 50-80

• Classified as being at increased risk of dementia based on at least one of the following:

  • First-degree family history of dementia
  • Education level at or below high school (grade 12 or less)
  • Self-Reported: Hypertension, Hypercholesterolemia, Body Mass Index > 30 kg/m2 (derived from NIH Metric BMI Calculator), or 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)

Exclusion criteria

• Individuals who have a clinical diagnosis of Dementia (based on self-report)
• Individuals who are currently participating in or have participated in a past study involving BHPro

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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700 participants in 2 patient groups

Immediate BHPro Intervention Group

Experimental group

Description:

Participants in this group will start Brain Health PRO immediately at baseline

Treatment:

Other: Brain Health PRO

Other: Brain Health PRO

Delayed Start BHPro

Other group

Description:

Participants in this group will start Brain Health PRO in 6 months (delayed)

Treatment:

Other: Brain Health PRO

Other: Brain Health PRO