Brain Health Support Program

Mild Cognitive Impairment Clinical Trial

— CTU: BHSP  

Official title:

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05347966
• Other study ID #: CTU: BHSP
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP, or CTU) is a comprehensive and innovative program aimed to develop, implement and evaluate an interactive and compelling online educational Brain Health Support Program (BHSP) intervention, called Brain Health PRO (BHPro), with potential to positively influence dementia literacy, lifestyle risk factors, and scale-up to reach the broader Canadian public; enroll and retain a community-dwelling Platform Trial Cohort (PTC) of individuals at risk of dementia; and support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Completion and documentation of the electronic Informed Consent Process (from the participant)

2. Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.

3. Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)

4. Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing

5. Ability to sit comfortably for a period of about 30 minutes

6. Ages 60-85

7. Meets criteria for No Dementia and meet criteria (according to CCNA Criteria, Appendix 1) of one of the following:

• Cognitively Unimpaired (CU)

• Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI)

• Mild Cognitive Impairment (MCI)

8. 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 years) on any of the following lifestyle 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)

9. Participant has a family physician or other healthcare provider and agrees to have the provider notified of participation in the study and incidental or other findings that may be clinically significant

Exclusion Criteria:

1. Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.

2. Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.

3. Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program

4. Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments

5. Individuals who have a clinical diagnosis of Dementia

6. Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1

7. Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Subjective Cognitive Impairment

Intervention

Other:
• Brain Health PRO
BHPro is a 45-week, multidomain web-based formal educational program which has been designed to increase dementia literacy, convey best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health.

Locations

Country	Name	City	State
Canada	Cape Breton University	Cape Breton	Nova Scotia
Canada	University of New Brunswick	Fredericton	New Brunswick
Canada	Cognitive Clinical Research Group, Parkwood Research Institute	London	Ontario
Canada	Gait and Brain Laboratory, Parkwood Research Institute	London	Ontario
Canada	CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal	Montréal	Quebec
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	Dementia Literacy	The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale.	12 months
Secondary	Self-efficacy	Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE).	12 months
Secondary	To evaluate usability of BHPro	Based on System Usability Scale	12 months
Secondary	To evaluate Engagement of BHPro	Number of chapters completed on BHPro	12 months
Secondary	To evaluate user acceptance of BHPro	Based on Technology Acceptance Model Questionnaire	12 months