Description

Introduction: Dementia represents a major and growing challenge for public health. Approximately 45% of dementia cases worldwide, and up to 49% in Canada, are attributable to modifiable risk factors. Multidomain prevention trials have demonstrated that targeting these risk factors can improve cognitive outcomes among at-risk individuals. However, such interventions are typically resource-intensive, rely on face-to-face supervision, and are difficult to scale across diverse and geographically dispersed populations. Brain Health PRO (BHPRO) is a six-month, web-based dementia risk reduction program co-developed with researchers and older adults across Canada. A prior multi-site efficacy trial involving 350 participants demonstrated significant improvements in dementia literacy, self-efficacy, and modifiable risk factors under controlled conditions. Despite demonstrated efficacy, successful translation into real-world settings requires systematic implementation strategies tailored to organizational context. This study evaluates real-world implementation of BHPRO across diverse Canadian community, clinical, and public health settings, with particular emphasis on rural and underserved populations. Phase 1 of this study (January 2025-2026) established formal partnerships with fourteen sites across seven Canadian provinces, conducted needs assessments, identified barriers and facilitators to implementation, and co-developed tailored, site-specific implementation strategies through collaborative planning with organizational stakeholders.

Objectives: The primary objective of this study is to evaluate implementation success of BHPRO across ten to fourteen Canadian sites by assessing adoption, implementation sustainability, and reach. Secondary implementation objectives include assessing perceived appropriateness and feasibility of the program and identifying contextual determinants that influence implementation success across settings. In parallel, effectiveness objectives at the end-user level include evaluating changes in dementia literacy, self-efficacy, composite modifiable dementia risk, individual modifiable risk domain scores, and cognitive performance, as well as assessing adherence, usability, and program acceptance.

Hypothesis: The central hypothesis is that BHPRO can be feasibly, appropriately, and sustainably implemented across diverse delivery channels in Canada through tailored, context-specific implementation strategies developed during Phase 1. It is hypothesized that at least 70% of eligible sites will adopt BHPRO within three months of rollout, at least 64% of adopting sites will sustain implementation at twelve months, and at least 67% of interested end users will enroll and initiate the program. It is further hypothesized that participating end users will demonstrate within-person improvements over time in dementia literacy, self-efficacy, composite modifiable risk profile, and cognitive performance. These benchmarks are derived from meta-analytic estimates in the implementation science literature and were used as the basis for formal power calculations.

Design: This study is a twelve-month, mixed-methods, multi-centre Hybrid Type III effectiveness-implementation study employing a single-arm design. Ten to fourteen Canadian sites, including community organizations, clinical settings, and public health agencies, will implement BHPRO using site-specific implementation toolkits co-developed during Phase 1, based on strategies identified using the Expert Recommendations for Implementing Change (ERIC) taxonomy and tailored to each site's context following Phase 1 needs assessments and barriers and facilitators analyses. Sites may adapt implementation approaches; these adaptations will be documented using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME). The rollout will be staggered over a three to four month period to ensure adequate research team support. Implementation outcomes are prioritized and will be measured at the site level at three, six, and twelve months using structured quantitative tools and qualitative methods including focus groups and interviews. Effectiveness outcomes will be measured at the individual participant level at baseline, mid-way, immediately post-intervention at six months, and at six-month follow-up (twelve months). The study does not involve randomization or masking. Approximately 350 end users are expected to participate across sites. Data collection includes online questionnaires, platform-based analytics, structured documentation of implementation processes through twice-monthly online meetings with site champions and validated computerized cognitive assessments. The design integrates quantitative and qualitative data to evaluate both implementation processes and participant-level outcomes under real-world conditions.