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Completed

NCT Number: NCT05347966

Brain Health Support Program

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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Key information

Conditions

Dementia Prevention Cognition Disorders Cognitive Change Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Subjective Cognitive Impairment

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Cognitively Unimpaired (CU)
  • Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI)
  • Mild Cognitive Impairment (MCI)
  • 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)

  • 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

  • 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.
  • Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
  • Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
  • 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
  • Individuals who have a clinical diagnosis of Dementia
  • Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1
  • Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13

Treatment and study plan

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.

Other names: BHPro

Primary outcomes

  1. Change in Dementia Literacy From Baseline to Month 12

    Time frame: 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 outcomes

  1. Change in Self-efficacy From Baseline to Month 12

    Time frame: 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.

  2. To Evaluate Usability of BHPro

    Time frame: 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.

  3. Number of Chapters Completed on BHPro

    Time frame: 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.

  4. To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Registry information

Official study title

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention

Acronym: CTU: BHSP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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