A Pilot Study for the Brain Health Support Program

Completed

• Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment; Pre-dementia; Dementia Prevention; Dementia
• Interventions: Behavioral: Brain Health PRO

• Registration Number: NCT05167045
• Lead Sponsor: Baycrest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study Start: 2021-11-15
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-22
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Dementia	Brain Health PRO	-

Primary Outcome Measures

Name	Time	Method
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
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
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)
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
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)

Trial Locations

Locations (3)

Baycrest; 🇨🇦 Toronto, Ontario, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of New Brunswick; 🇨🇦 Fredericton, New Brunswick, Canada