Recovery After Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in cardiac effort
研究概览
简要总结
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
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
- Single (Outcomes Assessor)
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
- •English speaking (>18 years old). Daily messages will be sent in English.
- •Acute PE with at least one of the following:
- •any right ventricular enlargement or dysfunction on echocardiogram;
- •CT Angiogram reporting any right ventricular enlargement; or
- •elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
- •Rate controlled atrial arrythmias (resting heart rate <110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
- •Subjects do need to take prescribed anticoagulation.
排除标准
- •Cardiac Effort >3.5 beats/m during 6MWT.
- •Resting tachycardia >110 beats/m at hospital discharge.
- •Chronic Thromboembolic Pulmonary Hypertension
- •Systolic blood pressure >180 mmHg at hospital discharge.
- •Inability to walk.
- •Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
- •Advanced neurologic disease and would not be able to comply with the messages.
- •Lack of access to email or text messaging
- •Inability or unwillingness to follow daily instructions.
研究组 & 干预措施
Healthy Living Intervention-1
Participants who receive daily messages about a healthy intervention.
干预措施: Healthy Living Intervention-1 (Behavioral)
Healthy Living Intervention-2
Participants who receive daily messages about a different healthy intervention.
干预措施: Healthy Living Intervention-2 (Behavioral)
结局指标
主要结局
Mean change in cardiac effort
时间窗: Baseline and 3 months
Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.
次要结局
- mean change in diagnoses(baseline and month 3)
- Mean number of health care visits (Health Care Utilization)(3 months)
- Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score(baseline and 3 months)
- Mean change in 6 minute walk distance(baseline and 3 months)
- Mean change in activity as measured by Actigraph(baseline and 3 months)
研究者
Daniel Lachant
Associate Professor
University of Rochester