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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Health PRO | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Health PRO | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dementia Literacy From Baseline to Month 12 | The primary outcome will be 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. This self-report questionnaire contains 30 true/false items. 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. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-efficacy From Baseline to 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. This self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). 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. To aide interpretation, change in GSE scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -7.39 to +7.39. The greater the change in score, the greater the increase in self-efficacy. |
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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 Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1] of one of the following:
AND Classified as being at increased risk of dementia based on at least one of the following:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada | ||
| University of New Brunswick |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40090784 | Derived | Belleville S, Anderson ND, Bherer L, Camicioli R, Carrier J, Chan S, Cuesta M, Dang-Vu TT, Dwosh E, Fiocco AJ, Ferland G, Gilbert B, Harris E, Itzhak I, Jarrett P, Kadri MA, Laurin D, Liu-Ambrose T, McGibbon CA, Middleton L, Miller L, Nygaard HB, Montero-Odasso M, Murphy K, Phillips N, Pichora-Fuller MK, Robillard JM, Smith EE, Speechley M, Trigui A, Wittich W, Chertkow H, Feldman HH; CTU expert group for the Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Brain health PRO/Sante cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction. J Prev Alzheimers Dis. 2025 Jun;12(6):100134. doi: 10.1016/j.tjpad.2025.100134. Epub 2025 Mar 15. | |
| 37874110 |
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Participants who did not meet eligibility criteria for the study screen-failed before the baseline visit.
Participants aged 60-85 who were cognitively unimpaired, or had subjective cognitive impairment, or mild cognitive impairment, and at least one pre-defined risk factor for dementia, among other specific criteria, were eligible to participate in this study. A total of 354 participants were enrolled at 7 centres across Canada. Recruitment began in April 2022 and the last participant exited the study in April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | BHSP-Main | Brain Health PRO (BHPro) is an innovative online platform designed to help reduce the risk of dementia by providing individuals with the tools and knowledge needed to make positive lifestyle changes. The program offers a flexible, user-friendly interface that allows users to assess their risk and engage with educational modules specifically tailored to their needs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 354 participants were eligible for the study with one participant requesting their data not be used, leaving 353 baseline participants to report on.
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| ID | Title | Description |
|---|---|---|
| BG000 | BHSP Main | Brain Health PRO (BHPro) is an innovative online platform designed to help reduce the risk of dementia by providing individuals with the tools and knowledge needed to make positive lifestyle changes. The program offers a flexible, user-friendly interface that allows users to assess their risk and engage with educational modules specifically tailored to their needs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Dementia Literacy From Baseline to Month 12 | The primary outcome will be 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. This self-report questionnaire contains 30 true/false items. 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. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia. | Intention To Treat (ITT) sample: Includes all participants who (1) meet screening criteria (2) and completed at least 1 assessment at baseline. Covariates include: age, sex, race, cognitive status, and Heaton education score. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | 12 months |
Adverse event data is collected from Baseline up to 30 days after study participation has ended. This is approximately 1 year for participants who remained in the study until the end and less time for those who withdrew early. Systematic collection of AEs occurred at the following study visits: Baseline, Month 6, Month 12. Non-systematic AE reporting, spontaneous reporting by participant, was also implemented.
The study protocol defines an adverse event (AE) as any unfavourable or unintended sign, symptom, or disease associated with study procedures that are both non-serious and either temporally or causally related to study procedures. To be reported as a Serious Adverse Event (SAE), the protocol requires that the event must be serious, unanticipated, and related to study procedures. All-cause mortality, SAEs, and Other (Not Including Serious) AEs not related to study procedures were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BHSP Main | Brain Health PRO (BHPro) is an innovative online platform designed to help reduce the risk of dementia by providing individuals with the tools and knowledge needed to make positive lifestyle changes. The program offers a flexible, user-friendly interface that allows users to assess their risk and engage with educational modules specifically tailored to their needs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Reaction likely related to EEG headband | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haakon Nygaard | UBC | 604-827-0600 | haakon.nygaard@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2023 | Feb 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2024 | Feb 26, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
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| 12 months |
| To Evaluate Usability of BHPro | Based on System Usability Scale (SUS). The SUS is an 11-item questionnaire with 5-point Likert scale. The total raw score ranges from 0-43 with a higher score indicating greater usability and satisfaction with Brain Health Pro. | 12 months |
| Number of Chapters Completed on BHPro | To evaluate engagement with Brain Health PRO, the number of chapters completed on BHPro was calculated. There is a total of 180 chapters (181 when orientation chapter is included) that are available on BHPro. The program allows participants to view 160 chapters (excluding the orientation chapter) when reaching week 45 (the intended length of the BHPro program). After 45 weeks, the remaining chapters that were still locked will become accessible for users interested in viewing all the program content. The range of chapters that could be completed on Brain Health PRo by participants is 1-181, with a higher number indicating higher engagement with the program. | 12 months |
| To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ). | Based on Technology Acceptance Model Questionnaire. The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro. | 12 months |
| Fredericton |
| New Brunswick |
| E3B 5A3 |
| Canada |
| Cape Breton University | Cape Breton | Nova Scotia | B1M 1A2 | Canada |
| Cognitive Clinical Research Group, Parkwood Research Institute | London | Ontario | N6C 5J1 | Canada |
| Gait and Brain Laboratory, Parkwood Research Institute | London | Ontario | N6C 5J1 | Canada |
| Baycrest | Toronto | Ontario | M6A 2E1 | Canada |
| CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal | Montreal | Quebec | H3W 1W5 | Canada |
| Derived |
| Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, Durant J, Lupo JL, Revta C, Chan S, Cuesta M, Slack PJ, Winer S, Brewster PWH, Hofer SM, Lim A, Centen A, Jacobs DM, Anderson ND, Walker JD, Speechley MR, Zou GY, Chertkow H. Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study. J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | BHSP Main | Brain Health PRO (BHPro) is an innovative online platform designed to help reduce the risk of dementia by providing individuals with the tools and knowledge needed to make positive lifestyle changes. The program offers a flexible, user-friendly interface that allows users to assess their risk and engage with educational modules specifically tailored to their needs. |
|
|
| Secondary | Change in Self-efficacy From Baseline to 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. This self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). 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. To aide interpretation, change in GSE scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -7.39 to +7.39. The greater the change in score, the greater the increase in self-efficacy. | Intention to Treat sample (ITT) sample: includes all participants who (1) meet screening criteria (2) and completed at least 1 assessment at baseline. Covariates include: age, sex, race, cognitive status, and Heaton education score | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | To Evaluate Usability of BHPro | Based on System Usability Scale (SUS). The SUS is an 11-item questionnaire with 5-point Likert scale. The total raw score ranges from 0-43 with a higher score indicating greater usability and satisfaction with Brain Health Pro. | 248 of 353 participants completed the System Usability Scale at month 12. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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|
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| Secondary | Number of Chapters Completed on BHPro | To evaluate engagement with Brain Health PRO, the number of chapters completed on BHPro was calculated. There is a total of 180 chapters (181 when orientation chapter is included) that are available on BHPro. The program allows participants to view 160 chapters (excluding the orientation chapter) when reaching week 45 (the intended length of the BHPro program). After 45 weeks, the remaining chapters that were still locked will become accessible for users interested in viewing all the program content. The range of chapters that could be completed on Brain Health PRo by participants is 1-181, with a higher number indicating higher engagement with the program. | Modified Intention To Treat (mITT) sample: Includes all eligible participants who (1) have completed at least one assessment for the outcome of interest and (2) registered for BHPro. | Posted | Mean | Standard Deviation | Chapters completed | 12 months |
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|
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| Secondary | To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ). | Based on Technology Acceptance Model Questionnaire. The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro. | 257 of 353 participants completed the Technology Acceptance Model Questionnaire at month 12. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 0 |
| 353 |
| 0 |
| 353 |
| 3 |
| 353 |
| Headache likely related to EEG headband | General disorders | Non-systematic Assessment |
|
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