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Brain Health Support Program (CTU: BHSP)

Primary Purpose

Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brain Health PRO
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia Prevention

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia
  • University of New Brunswick
  • Cape Breton University
  • Cognitive Clinical Research Group, Parkwood Research Institute
  • Gait and Brain Laboratory, Parkwood Research Institute
  • Baycrest
  • CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Brain Health PRO

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Self-efficacy
Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE).
To evaluate usability of BHPro
Based on System Usability Scale
To evaluate Engagement of BHPro
Number of chapters completed on BHPro
To evaluate user acceptance of BHPro
Based on Technology Acceptance Model Questionnaire

Full Information

First Posted
April 14, 2022
Last Updated
April 24, 2023
Sponsor
Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT05347966
Brief Title
Brain Health Support Program
Acronym
CTU: BHSP
Official Title
The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baycrest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment, Cognitive Change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain Health PRO
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Brain Health PRO
Other Intervention Name(s)
BHPro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dementia Literacy
Description
The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE).
Time Frame
12 months
Title
To evaluate usability of BHPro
Description
Based on System Usability Scale
Time Frame
12 months
Title
To evaluate Engagement of BHPro
Description
Number of chapters completed on BHPro
Time Frame
12 months
Title
To evaluate user acceptance of BHPro
Description
Based on Technology Acceptance Model Questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion and documentation of the electronic Informed Consent Process (from the participant) Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program. 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) Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing Ability to sit comfortably for a period of about 30 minutes Ages 60-85 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) 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) 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: 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. Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program. Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program 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 Individuals who have a clinical diagnosis of Dementia Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1 Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
University of New Brunswick
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5A3
Country
Canada
Facility Name
Cape Breton University
City
Cape Breton
State/Province
Nova Scotia
ZIP/Postal Code
B1M 1A2
Country
Canada
Facility Name
Cognitive Clinical Research Group, Parkwood Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Gait and Brain Laboratory, Parkwood Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Facility Name
CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3W 1W5
Country
Canada

12. IPD Sharing Statement

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Brain Health Support Program

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