Trial Outcomes & Findings for Brain Health Support Program (NCT NCT05347966)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

354 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-02

Participant Flow

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.

Participants who did not meet eligibility criteria for the study screen-failed before the baseline visit.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	354
Overall Study COMPLETED	315
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Health Support Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BHSP Main n=353 Participants 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.
Age, Continuous	69.7 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	245 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	352 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	318 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants
Race/Ethnicity, Customized Multiple Ethnicities	8 Participants n=5 Participants
Race/Ethnicity, Customized Other	15 Participants n=5 Participants
Region of Enrollment Canada	353 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	BHSP Main n=353 Participants 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.
Change in Dementia Literacy From Baseline to Month 12	0.191 Score on a scale Interval -0.014 to 0.397

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	BHSP Main n=353 Participants 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.
Change in Self-efficacy From Baseline to Month 12	0.157 score on a scale Interval 0.042 to 0.272

SECONDARY outcome

Timeframe: 12 months

Population: 248 of 353 participants completed the System Usability Scale at month 12.

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.

Outcome measures

Outcome measures
Measure	BHSP Main n=248 Participants 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.
To Evaluate Usability of BHPro	34 score on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	BHSP Main n=345 Participants 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.
Number of Chapters Completed on BHPro	142 Chapters completed Standard Deviation 60

SECONDARY outcome

Timeframe: 12 months

Population: 257 of 353 participants completed the Technology Acceptance Model Questionnaire at month 12.

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.

Outcome measures

Outcome measures
Measure	BHSP Main n=257 Participants 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.
To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).	94 score on a scale Standard Deviation 18

Adverse Events

BHSP Main

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BHSP Main n=353 participants at risk 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.
Skin and subcutaneous tissue disorders Skin Reaction likely related to EEG headband	0.57% 2/353 • Number of events 2 • 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.
General disorders Headache likely related to EEG headband	0.28% 1/353 • Number of events 1 • 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.

Additional Information

Dr. Haakon Nygaard

UBC

Phone: 604-827-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place