Patient Reported Outcomes in Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.

Detailed Description
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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.

Official Title
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Patient Reported Outcomes in Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Other: Interview
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I Patient Interviews<br>Indepth interviews will be completed with approximately 15 patients. | Other: Interview<br>* 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.<br>|
| Phase II Patient Questionnaire<br>Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I | Other: Questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for the study will be a composite symptom score derived from items in the instrument. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Instrument Development, Patient Reported Outcomes, Pulmonary Arterial Hypertension.