Patient Reported Outcomes in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- The primary endpoint for the study will be a composite symptom score derived from items in the instrument.
研究概览
简要总结
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
详细描述
This study will use the Clinical Impact Method to develop a patient reported outcome for use in patients with pulmonary arterial hypertension Clinical personnel at the study sites will approach and discuss possible participation in Phase I and II of the study with subjects from the existing pool of patients currently receiving usual and customary care at the site.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent
- •Subjects aged >=18 who have documented PAH
- •Speak English
- •Subjects who provide written informed consent to participate in the study before being screened for the study.
排除标准
- •Patients with non-PAH Pulmonary Hypertension
- •Physical inability to complete the interview process
- •Subjects who are currently enrolled in an experimental drug study
结局指标
主要结局
The primary endpoint for the study will be a composite symptom score derived from items in the instrument.
时间窗: Patients in Phase 1 and 2 shall be engaged in the study for approximately one hour's time; Phase 1 will take 3 to 6 weeks, and Phase 2 will proceed until sufficient sample size is obtained (saturation); we anticipate completion by September 2013.
Composite symptom score shall be derived from the actual items selected as a result of Phase 2. The final scoring logarithm shall provide a score for each dimension, as well as an anxiety/concern scale derived from single items from each of the dimensions, and a total score.
次要结局
未报告次要终点