NCT02032719Unknown3 期
Investigating Improved Self Management in Uncontrolled Systolic Hypertension
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- 24 hour ambulatory blood pressure mean
研究概览
简要总结
Patients who receive smartphone-assisted health coaching will have a significantly lower 24 hour ambulatory blood pressure mean than patients who receive just health coaching
详细描述
Primary Outcome Measure: Mean 24 hour ambulatory blood pressure
Secondary Outcome Measures: Profile of Mood States-SF Vigor Scale; Satisfaction with Life Scale; Positive and Negative Affect Schedule; Hospital Anxiety and Depression Scale; SF - 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 - 70 years old;
- •mean daytime systolic BP> 130 mm. Hg.
排除标准
- •Severe or end-stage organ disease (liver, kidney, heart, lung) or history of diabetic ketoacidosis, or any other illness with expected survival less than 1 year;
- •severe cognitive impairment;
- •diagnosed psychiatric illness or disability;
- •clinical significant cardiac arrhythmia;
- •symptomatic orthostatic hypertension;
- •pregnancy;
- •not fluent in english.
结局指标
主要结局
24 hour ambulatory blood pressure mean
时间窗: 6 months follow up from baseline
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
次要结局
- Quality of life self report measures(Baseline and 6 months followup)
研究者
Paul Ritvo
Principal Investigator
York University
研究点 (2)
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