The Brain Health PRO Online Risk Factor Reduction Study for The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Change in modifiable risk factors as measured by a 7-item composite dementia risk factor score after 6 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Immediate BHPro Intervention Group
Participants in this group will start Brain Health PRO immediately at baseline
干预措施: Brain Health PRO (Other)
Delayed Start BHPro
Participants in this group will start Brain Health PRO in 6 months (delayed)
干预措施: Brain Health PRO (Other)
结局指标
主要结局
Change in modifiable risk factors as measured by a 7-item composite dementia risk factor score after 6 months.
时间窗: Change from baseline to month 6
The primary outcome is the change in a composite modifiable risk score comprised of the following 7 lifestyle risk questionnaires: Physical Activity, Nutrition, Sleep, Cognitive Engagement, Social and Psychological Health, Vascular Health, and Vision and Hearing (each questionnaire is individually described under the secondary outcomes). Scores for each risk factor will be standardized (z-score transformation using cohort-wide mean and standard deviation at baseline). When necessary, scores will be multiplied by -1 so that positive scores reflect lower risk (e.g., greater engagement in physical activity). The participant-level mean risk score will be calculated which reflects the average z-score for the participant across the modifiable risk factors.
次要结局
- Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Physical Activity(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(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(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(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(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(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(Change from baseline to month 6)
- Change in self-efficacy as measured by the General Self-Efficacy Scale after 6 months.(Change from baseline to month 6)
- Change in dementia literacy as measured by the Alzheimer's Disease Knowledge Scale after 6 months.(Change from baseline to month 6.)
- Change in cognition as measured by the Cogniciti Brain Health Assessment after 6 months.(Change from baseline to month 6)
研究者
Haakon Nygaard
Associate Professor
University of British Columbia