Recruiting

BHPRO

Sponsor:

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Code:

NCT07935629

Conditions

Dementia

Alzheimer's Disease

Health Behavior

Implementation Science

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Brain Health PRO (BHPRO)

Study Details

Brief summary:

Brain Health PRO (BHPRO) is a 6-month, web-based dementia-risk-reduction program targeting modifiable risk factors for cognitive decline. This 12-months, multi-site, single-arm, mixed-methods implementation study (Hybrid Type III design) evaluates the real-world adoption, sustainability, and reach of BHPRO across 10-14 partner sites in Canada, spanning seven provinces, including community organizations, clinics, and a public-health agency, with emphasis on rural and underserved communities. Tailored implementation toolkits (BHPRO-ITs), co-developed during Phase 1 using the ERIC taxonomy, are deployed at each site. Implementation outcomes (adoption, sustainability, reach, appropriateness, feasibility) are assessed at provider and organizational levels via online questionnaires and twice-monthly champion meetings. Effectiveness outcomes (dementia literacy, self-efficacy, modifiable risk factor composite, cognition) are collected from end users (adults aged 50+, at risk of dementia) at baseline, 3 months, post-program (6 months), and follow-up (12 months).

Conditions

Dementia

Alzheimer's Disease

Health Behavior

Implementation Science

Cognitive Decline

Study ID

NCT07935629

Start date

Jun 16, 2026

Status verified date

Nov, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion criteria:

1. Sufficient proficiency in English and/or French to complete online assessment and participate in the program;
2. Sufficient technological ability to navigate web-based content and participate in the assessment and the program (i.e., access to internet, ability to send and receive a message, ability to complete online assessment);
3. Vision sufficient to participate in the program;
4. Aged 50 years and older;
5. Classified as being at increased risk based on one of the following:

5.1. First-degree family history of dementia; 5.2. Formal education at or below 12 years; 5.3. Self-reported 5.3.1. Hypertension 5.3.2. Hypercholesterolemia 5.3.3. High body mass index (>30 kg/m2) 5.3.4. Physical inactivity (less than 20 to 30 minutes of physical activity, 2 times a week).

Exclusion criteria

1. Persons with a diagnosis of dementia (based on self-report).
2. Persons who have participated or are currently participating in other studies involving BHPRO.

Study Design

Enrollment

434 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: BHPRO Implementation

All participating sites implement BHPRO, a six-month, web-based dementia risk reduction program, using tailored implementation toolkits co-developed during Phase 1. Eligible end users at each site are offered access to the intervention. The study employs a single-group assignment without randomization or masking. Implementation is staggered across ten to fourteen Canadian sites, including community organizations, clinical settings, and one public health agency. The primary focus of the study is evaluation of implementation outcomes (adoption, sustainability, reach), while participant-level effectiveness outcomes are measured concurrently.

Interventions

Brain Health PRO (BHPRO)

A 6-month, web-based dementia-risk-reduction program consisting of eight modules addressing modifiable risk factors: physical activity, diet, cognitive engagement, sleep, social and psychological health, vascular health, and vision/hearing health. Upon registration, participants complete baseline lifestyle questionnaires that generate a personalized risk profile. Participants are instructed to prioritize three risk domains based on their profile and receive tailored content accordingly. Materials include narrated educational content, visual aids, quizzes, interactive exercises, and evidence-based recommendations. Content is delivered gradually (four 10-minute chapters per week). All modules remain accessible throughout participation. Program engagement metrics, including chapter completion, are automatically captured through the platform.

Primary outcome measure

  • Implementation outcome = Adoption [ Time Frame: 3 months after rollout initiation at each site ]
  • Implementation outcome = Sustainability [ Time Frame: 12 months after rollout initiation at each site ]
  • Implementation outcome = Reach [ Time Frame: 6 months and 12 months after rollout ]
  • Implementation outcome = Barriers and Facilitators to Implementation (Qualitative) [ Time Frame: 3, 6, and 12 months post-rollout ]

Central Contacts and Locations

Central contacts

Sylvie Belleville, PhD

514 340 3540sylvie.belleville@umontreal.ca

Locations

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Recruiting

Montreal, Quebec, Canada, H3W 1W6

Contacts

Sylvie Belleville, PhD

514 340 3540sylvie.belleville@umontreal.ca

More Information

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • Dementia prevention
  • Implementation science
  • Hybrid effectiveness-implementation
  • Cognition
  • Brain and cognitive health
  • Digital health intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.