I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 6
- 主要终点
- Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
研究概览
简要总结
I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 46 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 1 OR Stage 2 hypertension
- •46 -74 years of age
- •able to read & write English or French
- •living in private residence
排除标准
- •Cardiovascular disease
- •Major psychiatric disorder (e.g. psychosis)
- •Dependence on Alcohol or Drugs with in past year
- •Diabetes >= 5 years
结局指标
主要结局
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
时间窗: 4 months
次要结局
- Lifestyle Behavior: exercise and diet assessed by questionnaire(4 months)
- laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity(4 months)
研究者
Robert Nolan
Principal Investigator
University Health Network, Toronto