Pulmonary Arterial Hypertension
Conditions
Keywords
Instrument Development, Patient Reported Outcomes, Pulmonary Arterial Hypertension.
Brief summary
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
Detailed description
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.
Interventions
OTHERInterview
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.
OTHERQuestionnaire
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.
Sponsors
University of Chicago
Mayo Clinic
Vanderbilt University
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint for the study will be a composite symptom score derived from items in the instrument. | 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. |
Outcome results
None listed