Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- lipoprotein cholesterol
研究概览
简要总结
This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and adherence to prescribed medications. Finally, we will quantify the amount of e-counseling support that is required during REACH to evoke a significant reduction in blood pressure. It is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide information that is critical to our understanding of how internet-based programs can help to improve blood pressure and to reduce the risk for cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 35-74 years
- •Diagnosis of hypertension: Medication or physician confirmation
- •Baseline BP in lab: >=140/90 (if no meds); >=130/85 (if on meds)
- •If medications, prescription unchanged >=2 months Comprehension of English (oral and written)
排除标准
- •diagnosis of clinically significant arrhythmia, sleep apnea, kidney disease, major psychiatric illness (eg. psychosis), alcohol or drug dependence in the previous year; institutional residence, or an inability to comprehend English
研究组 & 干预措施
e-Counseling plus Usual Care
干预措施: e-Counseling plus Usual Care (Behavioral)
e-Info Control plus Usual Care
干预措施: Control (Behavioral)
结局指标
主要结局
lipoprotein cholesterol
时间窗: 12-month
total, low-density, and total/high-density ratio
Blood Pressure
时间窗: 12-month
Systolic blood pressure, diastolic blood pressure, pulse pressure
10-year absolute risk for Cardiovascular Heart Disease.
时间窗: 12-month
次要结局
- 24-hour urinary sodium excretion(12-month)
- Fruit and vegetable intake(12-month)
- 4-day step count recorded by accelerometry(12-month)
- salivary cotinine(12-month)