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

January 15, 2026 updated by: Howard Chertkow, Baycrest

A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of British Columbia
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5A3
        • University of New Brunswick
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will recruit it's cohort from various locations around Canada.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functionality of the BHSP
Time Frame: Nov 2021-Mar 2022
Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions
Nov 2021-Mar 2022
User acceptance of the BHSP
Time Frame: 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
Nov 2021-Mar 2022
Usability of the BHSP
Time Frame: Nov 2021-Mar 2022
User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)
Nov 2021-Mar 2022
To assess participant satisfaction with the organization, presentation and personalization of the BHSP content
Time Frame: Nov 2021-Mar 2022
Qualitative evaluation of participant responses during the focus group discussion
Nov 2021-Mar 2022
To evaluate the feasibility of remote data collection
Time Frame: 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)
Nov 2021-Mar 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baycrest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTU BHSP-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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