CTU BHSP-P: A Pilot Study for the Brain Health Support Program

Baycrest (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, investigators have developed the CAN-THUMBS UP program to conduct studies that target lifestyle risk and focus on dementia prevention. An online Brain Health Support Program (BHSP) has been developed. The BHSP is an educational program designed to teach about dementia. Before the full BHSP is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brain Health PRO

Study Design

Study Type:
Actual Enrollment :
20 participants
Observational Model:
Time Perspective:
Official Title:
A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia
Actual Study Start Date :
Nov 15, 2021
Actual Primary Completion Date :
Apr 29, 2022
Actual Study Completion Date :
Apr 29, 2022

Arms and Interventions

Arm Intervention/Treatment
No Dementia

Behavioral: Brain Health PRO
The BHSP is an educational program designed to teach about dementia. It aims to provide best available evidence for lifestyle changes that can help lower dementia risk, and to provide specific recommendations for positive lifestyle changes (e.g., physical exercises to try at home, healthy recipes). The program was developed as a collaborative effort by Canadian investigators who have expertise in the different areas of dementia prevention, along with input from older-adult citizen advisors.
Other Names:
  • Brain Health Support Program
  • Outcome Measures

    Primary Outcome Measures

    1. Functionality of the BHSP [Nov 2021-Mar 2022]

      Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions

    2. User acceptance of the BHSP [Nov 2021-Mar 2022]

      User adherence and engagement using the online program during the pilot including dates and times of use, duration of use and completion of program assessments

    3. Usability of the BHSP [Nov 2021-Mar 2022]

      User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)

    4. To assess participant satisfaction with the organization, presentation and personalization of the BHSP content [Nov 2021-Mar 2022]

      Qualitative evaluation of participant responses during the focus group discussion

    5. To evaluate the feasibility of remote data collection [Nov 2021-Mar 2022]

      User data, feedback and adherence to remote measures, such as: Screening evaluation by tele/video-conference, Neuropsychological Test Battery, Burst cognitive testing with the MyCogHealth app, online version of the Cogstate Brief Battery, Assessments of lifestyle risk factors (sleep, diet, mood, cognition, physical activity, vascular health, social and psychological health, vision and hearing), Actigraphy and EEG wearables as measures of total daily physical activity and sleep fragmentation, and Saliva sample collection for genomics testing (Polygenic Hazard Score)

    Eligibility Criteria


    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Meets criteria for No Dementia and one of the following (according to CCNA criteria):

    Cognitively Intact (CI) Cognitively Intact plus Subjective Cognitive Impairment (CI + 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) on any of the following 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)

    Contacts and 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 Baycrest Toronto Ontario Canada M6A 2E1

    Sponsors and Collaborators

    • Baycrest


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Howard Chertkow, Scientific Director, Canadian Consortium on Neurodegeneration in Aging, Baycrest
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • CTU BHSP-P
    First Posted:
    Dec 22, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022