A Pilot Study for the Brain Health Support Program

Dementia Clinical Trial

— CTU BHSP-P  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167045
• Other study ID #: CTU BHSP-P
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: July 2022
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Subjective Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Canada	University of New Brunswick	Fredericton	New Brunswick
Canada	Baycrest	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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