Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)
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|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Recruitment Status : Withdrawn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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792622
|Study Director:||Pfizer CT.gov Call Center||Pfizer|