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

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: Completed
• Conditions: Dementia; Mild Cognitive Impairment; Dementia Prevention; Subjective Cognitive Impairment; Pre-dementia
• Intervention / Treatment: Behavioral: Brain Health PRO

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality of the BHSP	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	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	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	Qualitative evaluation of participant responses during the focus group discussion	Nov 2021-Mar 2022
To evaluate the feasibility of remote data collection	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

• Sponsor: Baycrest

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2021
• Primary Completion (ACTUAL): April 29, 2022
• Study Completion (ACTUAL): April 29, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID 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