Brain Health Support Program

NCT ID: NCT05347966

Last Updated: 2025-05-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2024-04-19

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia Prevention Mild Cognitive Impairment Subjective Cognitive Impairment Cognitive Change

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Brain Health PRO

Group Type OTHER

Brain Health PRO

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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BHPro

Eligibility Criteria

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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 \[according to Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1\] 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of New Brunswick

Fredericton, New Brunswick, Canada

Site Status

Cape Breton University

Cape Breton, Nova Scotia, Canada

Site Status

Cognitive Clinical Research Group, Parkwood Research Institute

London, Ontario, Canada

Site Status

Gait and Brain Laboratory, Parkwood Research Institute

London, Ontario, Canada

Site Status

Baycrest

Toronto, Ontario, Canada

Site Status

CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Belleville S, Anderson ND, Bherer L, Camicioli R, Carrier J, Chan S, Cuesta M, Dang-Vu TT, Dwosh E, Fiocco AJ, Ferland G, Gilbert B, Harris E, Itzhak I, Jarrett P, Kadri MA, Laurin D, Liu-Ambrose T, McGibbon CA, Middleton L, Miller L, Nygaard HB, Montero-Odasso M, Murphy K, Phillips N, Pichora-Fuller MK, Robillard JM, Smith EE, Speechley M, Trigui A, Wittich W, Chertkow H, Feldman HH; CTU expert group for the Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Brain health PRO/Sante cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction. J Prev Alzheimers Dis. 2025 Jun;12(6):100134. doi: 10.1016/j.tjpad.2025.100134. Epub 2025 Mar 15.

Reference Type DERIVED
PMID: 40090784 (View on PubMed)

Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, Durant J, Lupo JL, Revta C, Chan S, Cuesta M, Slack PJ, Winer S, Brewster PWH, Hofer SM, Lim A, Centen A, Jacobs DM, Anderson ND, Walker JD, Speechley MR, Zou GY, Chertkow H. Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study. J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65.

Reference Type DERIVED
PMID: 37874110 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CTU: BHSP

Identifier Type: -

Identifier Source: org_study_id

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