Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)
|ClinicalTrials.gov Identifier: NCT01792622|
Recruitment Status : Withdrawn
First Posted : February 15, 2013
Last Update Posted : August 1, 2013
|Condition or disease||Intervention/treatment|
|Pulmonary Arterial Hypertension||Other: Interview Other: Questionnaire|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Patient Reported Outcomes in Pulmonary Arterial Hypertension|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792622
|Study Director:||Pfizer CT.gov Call Center||Pfizer|