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NCT01792622 Clinical Trial

Patient Reported Outcomes in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— PROPAH  

Official title:
Patient Reported Outcomes in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01792622
Other study ID # A1481296
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 2013
Est. completion date September 2013

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Interview
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.
• Questionnaire
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.

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Mayo Clinic, University of Chicago, Vanderbilt University

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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