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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792622
|Study Director:||Pfizer CT.gov Call Center||Pfizer|