Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Patient Reported Outcomes in Pulmonary Arterial Hypertension|
- 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. ] [ Designated as safety issue: No ]
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.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Phase I Patient Interviews
Indepth interviews will be completed with approximately 15 patients.
Patients will be interviewed to provide descriptive information about their experience as a treated patient with pulmonary arterial hypertension. The interviews will be given one time for approximately 1 hour.
Phase II Patient Questionnaire
Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I
Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I. The questionnaire will be given one time for approximately 1 hour.
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.