Activity Monitoring in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Activity Monitoring
研究概览
简要总结
This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.
详细描述
A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in L-PVDOMICS or
- •Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis
排除标准
- •Pregnancy
- •Hospitalization within the prior 3 months
- •Orthopedic limitations that preclude 6MWD testing
结局指标
主要结局
Activity Monitoring
时间窗: 3 year
Participants will wear an accelerometer to record activity level
次要结局
- Six Minute Walk Distance (6MWD) Test(Baseline, 1 year, 2 year, 3 year)
- emPHasis-10(Baseline, 1 year, 2 year, 3 year)
- Intensity of Activity(Baseline, 1 year, 2 year, 3 year)
- Quality of Life 36-Item Short Form Survey (SF-36)(Baseline, 1 year, 2 year, 3 year)
- Minnesota Living with Heart Failure (MLHF)(Baseline, 1 year, 2 year, 3 year)
研究者
Evan Brittain
Assistant Professor of Medicine
Vanderbilt University Medical Center