Cognitive Change, Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment
Conditions
Brief summary
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.
Interventions
OTHERBrain Health PRO
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.
Sponsors
Baycrest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Completion and documentation of the electronic Informed Consent Process (from the participant) 2. Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program. 3. 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) 4. Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing 5. Ability to sit comfortably for a period of about 30 minutes 6. Ages 60-85 7. 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: * Cognitively Unimpaired (CU) * Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI) * Mild Cognitive Impairment (MCI) 8. AND Classified as being at increased risk of dementia based on at least one of the following: * First-degree family history of dementia * Self-Reported or documented current and/or history at midlife (45-60 years) on any of the following lifestyle risk factors: 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) 9. 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
1. Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation. 2. Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program. 3. Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program 4. Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments 5. Individuals who have a clinical diagnosis of Dementia 6. Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of \>1 7. Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) \<13
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dementia Literacy From Baseline to Month 12 | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-efficacy From Baseline to Month 12 | 12 months | 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. |
| To Evaluate Usability of BHPro | 12 months | 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. |
| Number of Chapters Completed on BHPro | 12 months | 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. |
| To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ). | 12 months | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
Participants who did not meet eligibility criteria for the study screen-failed before the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 353 |
| Total | 353 |
Baseline characteristics
| Characteristic | BHSP Main |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 352 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Multiple Ethnicities | 8 Participants |
| Race/Ethnicity, Customized Other | 15 Participants |
| Race/Ethnicity, Customized White | 318 Participants |
| Region of Enrollment Canada | 353 participants |
| Sex: Female, Male Female | 245 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 353 |
| other Total, other adverse events | 3 / 353 |
| serious Total, serious adverse events | 0 / 353 |
Outcome results
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BHSP Main | Change in Dementia Literacy From Baseline to Month 12 | 0.191 Score on a scale |
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.
Time frame: 12 months
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BHSP Main | Change in Self-efficacy From Baseline to Month 12 | 0.157 score on a scale |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BHSP Main | Number of Chapters Completed on BHPro | 142 Chapters completed | Standard Deviation 60 |
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.
Time frame: 12 months
Population: 248 of 353 participants completed the System Usability Scale at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BHSP Main | To Evaluate Usability of BHPro | 34 score on a scale | Standard Deviation 6 |
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.
Time frame: 12 months
Population: 257 of 353 participants completed the Technology Acceptance Model Questionnaire at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BHSP Main | To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ). | 94 score on a scale | Standard Deviation 18 |