The Brain Health PRO Online Risk Factor Reduction Study to Prevent Dementia

Официальное название

The Brain Health PRO Online Risk Factor Reduction Study for The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia

Обзор

This study will recruit participants at risk for dementia to participate in an online educational program called Brain Health PRO (BHPro). The BHPro intervention is designed to address modifiable risk factors for dementia through a 6-month, fully online, educational program conveying the best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health. Achieving lifestyle changes in a diverse Canadian population through online education would be a major achievement in dementia prevention in Canada, with widespread personal and socioeconomic benefits. Eligible participants will be randomly assigned to either start Brain Health PRO immediately or in 6 months (delayed-start control group). All participants will have the opportunity to have access to BHPro for 6 months during the course of the study and will have open access to all content for 12 months following the initial 6-month intervention. Participation will last from 18-24 months depending on group assignment.

Вмешательства

• Другое Brain Health PRO
  Immediate start of 6-month Brain Health PRO Intervention
• Другое Brain Health PRO
  Delayed start of 6-month Brain Health PRO

Первичные конечные точки

• Change in modifiable risk factors as measured by a 7-item composite dementia risk factor score after 6 months. [Срок оценки: Change from baseline to month 6]

Вторичные конечные точки (10)

• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Physical Activity [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Nutrition [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Sleep [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Cognitive Engagement [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Social and Psychological Health [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Vascular Health [Срок оценки: Change from baseline to month 6]
• Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Vision and Hearing [Срок оценки: Change from baseline to month 6]
• Change in self-efficacy as measured by the General Self-Efficacy Scale after 6 months. [Срок оценки: Change from baseline to month 6]
• Change in dementia literacy as measured by the Alzheimer's Disease Knowledge Scale after 6 months. [Срок оценки: Change from baseline to month 6.]
• Change in cognition as measured by the Cogniciti Brain Health Assessment after 6 months. [Срок оценки: Change from baseline to month 6]

Критерии участия

Критерии включения

• Completion and documentation of the electronic Informed Consent Process (from the participant)
• Sufficient proficiency in English or French to undergo online assessments and participate in an online educational program.
• Technical ability to participate in an online educational program and remote assessments (i.e., regularly have access to a computer or tablet with an internet connection; have access to a desktop or laptop computer with an internet connection at least once every 6 months; ability to send and receive emails; ability to complete online assessments)
• Sufficient vision to participate in an online educational program and complete online cognitive testing
• Ages 50-80
• Classified as being at increased risk of dementia based on at least one of the following:

• First-degree family history of dementia
• Education level at or below high school (grade 12 or less)
• Self-Reported: Hypertension, Hypercholesterolemia, Body Mass Index > 30 kg/m2 (derived from NIH Metric BMI Calculator), or 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)

Критерии исключения

• Individuals who have a clinical diagnosis of Dementia (based on self-report)
• Individuals who are currently participating in or have participated in a past study involving BHPro

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• University of British Colubmia — Vancouver

Идентификаторы

NCT: NCT07364019 · H25-03523

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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