Clinical trial NCT05347966: Brain Health Support Program
Official title: The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Prevention
Mild Cognitive Impairment
Subjective Cognitive Impairment
Cognitive Change
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 354
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Dementia Literacy From Baseline to Month 12
timeFrame: 12 months
Secondary outcomes:
measure: Change in Self-efficacy From Baseline to Month 12
timeFrame: 12 months
measure: To Evaluate Usability of BHPro
timeFrame: 12 months
measure: Number of Chapters Completed on BHPro
timeFrame: 12 months
measure: To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
city: Cape Breton
country: Canada
facility: Cape Breton University
state: Nova Scotia
city: London
country: Canada
facility: Cognitive Clinical Research Group, Parkwood Research Institute
state: Ontario
city: London
country: Canada
facility: Gait and Brain Laboratory, Parkwood Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
city: Montréal
country: Canada
facility: CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal
state: Quebec
Study officials:
References: