Patient Reported Outcomes in Pulmonary Arterial Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- The primary endpoint for the study will be a composite symptom score derived from items in the instrument.
Study Overview
Brief Summary
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with non-PAH Pulmonary Hypertension
- •Physical inability to complete the interview process
- •Subjects who are currently enrolled in an experimental drug study
Outcomes
Primary Outcomes
The primary endpoint for the study will be a composite symptom score derived from items in the instrument.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported