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Implementing Brain Health PRO Across Diverse Settings: A Multi-Site Implementation Study (BHPRO-IMP)

6 listopada 2026 zaktualizowane przez: Sylvie Belleville, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Implementing Brain Health PRO - A Dementia Risk Reduction Program - Across Diverse Settings, With Emphasis on Rural and Underserved Communities: Phase 2

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).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

434

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Quebec
      • Montreal, Quebec, Kanada, H3W 1W6
        • Rekrutacyjny
        • Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Implementation outcome = Adoption
Ramy czasowe: 3 months after rollout initiation at each site

The delivery of the intervention by the sites. Measure: Site implementation logs and twice-monthly champion reports; quantitative questionnaires Benchmark: ≥70% of sites adopt within 3 months of rollout.

3 months after rollout initiation at each site
Implementation outcome = Sustainability
Ramy czasowe: 12 months after rollout initiation at each site

The extent to which the intervention continues to be delivered by the sites one year after starting implementation.

Measure: Site implementation logs; program delivery logs; site documentation; focus groups.

Benchmark: ≥64% of adopting sites.

12 months after rollout initiation at each site
Implementation outcome = Reach
Ramy czasowe: 6 months and 12 months after rollout

Participants from the sites who start the program. Benchmark: ≥67%. BHPRO platform analytics (automated backend); Reach Reporter (site champions, every 6 months).

6 months and 12 months after rollout
Implementation outcome = Barriers and Facilitators to Implementation (Qualitative)
Ramy czasowe: 3, 6, and 12 months post-rollout

Multi-level barriers and facilitators to BHPRO adoption and sustainability. Measurements: Semi-structured focus groups with site staff (60-90 min, audio-recorded, transcribed verbatim); monthly online meetings with site champions; analyzed using reflexive thematic analysis (inductive + deductive CFIR/RE-AIM framework). NVivo. ~20% double-coded.

3, 6, and 12 months post-rollout

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Implementation outcome = Appropriateness
Ramy czasowe: 6 months post-rollout

The perceived fit, relevance, and compatibility of Brain Health PRO and of the Brain Health PRO Implementation Toolkit for the setting, as perceived by providers and organizational staff.

Measurements: Intervention Appropriateness Measure (IAM); a validated 4-item questionnaire. Each item is rated on a 5-point Likert scale. Item responses are averaged to produce the scale score.

Unit of Measure: Mean Intervention Appropriateness Measure score (range 4-20; higher = greater perceived appropriateness).

6 months post-rollout
Implementation outcome = Feasibility
Ramy czasowe: 3, 6, and 12 months post-rollout

The extent to which Brain Health PRO can be successfully used or carried out within a given setting, as perceived by providers and organizational staff.

Measurements: Feasibility of Intervention Measure (FIM); a validated 4-item questionnaire. Each item is rated on a 5-point Likert scale. Item responses are averaged to produce the scale score.

Unit of Measure: Mean Feasibility of Intervention Measure score (range 4-20; higher = greater perceived feasibility).

3, 6, and 12 months post-rollout
Effectiveness outcome = Dementia Literacy
Ramy czasowe: Baseline; immediately post-program (month 6); 6-month follow-up (month 12)

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.

Measurements: This self-report questionnaire contains 30 true/false items. Unit of measure: 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.

Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Self-Efficacy
Ramy czasowe: Baseline; immediately post-program (month 6); 6-month follow-up (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.

Measurements: his self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true).

Unit of measure: Responses are provided on a Likert scale. 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

Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Composite Modifiable Risk Factor Score
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Change in composite score across 7 BHPRO dementia-risk domains: physical activity, nutrition, sleep, cognitive engagement, social and psychological health, vascular health, and vision and hearing. Details for each questionnaire are provided under separate outcomes.

Measurements: Scores for each risk factor will be standardized (z-score transformation using cohort-wide mean and standard deviation at baseline). When necessary, scores will be multiplied by -1 so that positive scores reflect lower risk. The participant-level mean risk score will be calculated which reflects the average z-score for the participant across the modifiable risk factors.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Physical Activity
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: The International Physical Activity Questionnaire-Short Form is a brief 7-item self-report measure that captures types of and intensity of physical activity and sitting time.

Measurements: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0-9, with a higher score indicating more physical activity.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Nutrition
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: Shorter 11-item version of the Eating Pattern Self-Assessment Questionnaire developed by CCNA Team 5.

Measurement: The total score is calculated by calculating the accrued number of points assigned per question. The total score ranges between 0 and 22, with a higher score indicating more healthy eating habits.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Sleep
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: Brief 10-item questionnaire developed by BHPro sleep module content leads that assesses sleep duration, sleep patterns, and difficulties and daytime fatigue over the past 3 months.

Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 1 and 20, with a higher score indicating healthier sleep.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Cognitive Engagement
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: A 6-item questionnaire assessing types and duration of cognitively engaging activities.

Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0 and 36, with a higher score indicating more cognitively stimulating activities.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Social and Psychological Health
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: An 8-item questionnaire comprising 1 item on loneliness, 1 item on ageism, 1 item on subjective age, 1 item on essentialist beliefs of aging and 4 items on depression, anxiety, stress, and social support from STOP-D.

Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -1 and 50, with a higher score indicating poorer social and psychological health.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Vascular Health
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: 12-item self-report questionnaire developed by the BHPro Vascular Health team based on the American Heart Association's Life's Simple Seven checklist of the main risk factors for heart disease and stroke.

Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -4 and 8, with a higher score indicating better vascular health.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Vision and Hearing
Ramy czasowe: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)

Description: 10-item questionnaire developed by BHSP Vision and Hearing Module content leads that assesses perceived visual and auditory ability and actions taken to address potential vision/hearing difficulties.

Measurement: The total score is calculated by summing the accrued number of points assigned per question. If a user selects "Yes" for example, they receive 2 points for that question. The total score ranges between 0 and 20 points, with a higher score indicating poorer vision and hearing.

Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Cognition
Ramy czasowe: Baseline; immediately post-program (month 6); 6-month follow-up (month 12)

Change in cognition as measured by the Cogniciti Brain Health Assessment after 6 months.

Description: The Cogniciti Brain Health Assessment (BHA) is a self-administered validated computerized cognitive assessment comprised of four tests (Spatial Working Memory, Stroop Interference, Face-Name Association, and Number-Letter Alternation).

Measurement: The overall Cogniciti Brain Health Assessment score ranges from 0-100 with a higher score indicating better cognition.

Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Adherence
Ramy czasowe: Continuously tracked throughout the program duration (months 1-6); reported at post-program (month 6)

Proportion of BHPRO chapters completed. Target benchmark: ≥80% chapter completion.

Measurements: BHPRO platform engagement log (number of chapters completed out of total available).

Continuously tracked throughout the program duration (months 1-6); reported at post-program (month 6)
Effectiveness outcome = Usability
Ramy czasowe: Immediately post-program (month 6)

Usability of the Brain Health PRO platform, assessed with the System Usability Scale (SUS).

Measurements: The SUS is a 10-item questionnaire; each item is rated on a 5-point Likert scale (from strongly disagree to strongly agree), worded in reference to Brain Health PRO. Item responses are transformed and summed to a raw score of 0-40, then multiplied by 2.5 to yield a total score ranging from 0 to 100. Benchmarks: scores above 68 indicate satisfactory usability; scores above 80 indicate excellent usability.

Unit of Measure: Total SUS score (range 0-100; higher = better usability).

Immediately post-program (month 6)
Effectiveness outcome = Technology acceptance
Ramy czasowe: Immediately post-program (Month 6)

Acceptance of the Brain Health PRO (BHPRO) platform will be assessed using the Technology Acceptance Model Questionnaire (TAMQ).

Measurements: The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale.

Unit of Measure: Responses are provided on a Likert scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro.

Immediately post-program (Month 6)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Sylvie Belleville, PhD, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

25 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CRIUGM-009

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified individual participant data underlying all published primary and secondary analyses, accompanied by a data dictionary and statistical analysis plan, will be made available upon reasonable request, subject to ethics committee review and approval and in accordance with the terms of participant informed consent. Qualitative data (focus group transcripts) will not be shared due to re-identification risk. Requests should be directed to the principal investigator at the coordinating site. Data will be retained on secure servers at the Centre de recherche de l'Institut Universitaire de Gériatrie de Montréal for at least 10 years from final enrollment.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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