Clincosm LogoSign in Get a demo

CTU: BHSP: Brain Health Support Program

Sponsor
Baycrest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05347966
Collaborator
(none)
350
Enrollment
6
Locations
1
Arm
19
Anticipated Duration (Months)
58.3
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Brain Health PRO
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Brain Health PRO

Other: Brain 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.
Other Names:
  • BHPro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dementia Literacy [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.

    Secondary Outcome Measures

    1. Self-efficacy [12 months]

      Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE).

    2. Change in attitudes toward dementia [12 months]

      Measured by Sections B and D of the Perceptions Regarding Investigational Screening for Memory in Primary Care (PRISM-PC)

    3. Modifiable risk factors [12 months]

      Measured by BHPro Lifestyle Risk Questionnaires

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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 CCNA Criteria, Appendix

    1. of one of the following:

    • Cognitively Unimpaired (CU)

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

    • Mild Cognitive Impairment (MCI)

    1. 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)

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of British Columbia Vancouver British Columbia Canada V6T 1Z4
    2 University of New Brunswick Fredericton New Brunswick Canada E3B 5A3
    3 Cognitive Clinical Research Group, Parkwood Research Institute London Ontario Canada N6C 5J1
    4 Gait and Brain Laboratory, Parkwood Research Institute London Ontario Canada N6C 5J1
    5 Baycrest Toronto Ontario Canada M6A 2E1
    6 CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal Montréal Quebec Canada H3W 1W5

    Sponsors and Collaborators

    • Baycrest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baycrest
    ClinicalTrials.gov Identifier:
    NCT05347966
    Other Study ID Numbers:
    • CTU: BHSP
    First Posted:
    Apr 27, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dementia
    Cognitive Dysfunction

    Study Results

    No Results Posted as of May 27, 2022