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

• Sponsor: Baycrest (Other)
• Overall Status: Completed
• CT.gov ID: NCT05167045
• Collaborator: (none)
• Enrollment: 20
• Locations: 3
• Actual Duration (Months): 5.4
• Patients Per Site: 6.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Mild Cognitive Impairment; Subjective Cognitive Impairment; Pre-dementia; Dementia Prevention	Behavioral: Brain Health PRO

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 15, 2021
• Actual Primary Completion Date: Apr 29, 2022
• Actual Study Completion Date: Apr 29, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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)

4. 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

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of British Columbia	Vancouver	British Columbia	Canada	V6T 1Z4
2	University of New Brunswick	Fredericton	New Brunswick	Canada	E3B 5A3
3	Baycrest	Toronto	Ontario	Canada	M6A 2E1

Sponsors and Collaborators

• Baycrest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard Chertkow, Scientific Director, Canadian Consortium on Neurodegeneration in Aging, Baycrest
• ClinicalTrials.gov Identifier: NCT05167045
• Other Study ID Numbers: CTU BHSP-P
• First Posted: Dec 22, 2021
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 21, 2022