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A Pilot Study for the Brain Health Support Program

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05167045
Acronym
CTU BHSP-P
Enrollment
20
Registered
2021-12-22
Start date
2021-11-15
Completion date
2022-04-29
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Dementia Prevention, Mild Cognitive Impairment, Pre-dementia, Subjective Cognitive Impairment

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.

Interventions

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.

Sponsors

Baycrest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Functionality of the BHSPNov 2021-Mar 2022Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions
User acceptance of the BHSPNov 2021-Mar 2022User adherence and engagement using the online program during the pilot including dates and times of use, duration of use and completion of program assessments
Usability of the BHSPNov 2021-Mar 2022User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)
To assess participant satisfaction with the organization, presentation and personalization of the BHSP contentNov 2021-Mar 2022Qualitative evaluation of participant responses during the focus group discussion
To evaluate the feasibility of remote data collectionNov 2021-Mar 2022User 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026