Patient Reported Outcomes in Pulmonary Arterial Hypertension

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: Interview; Other: Questionnaire

• Registration Number: NCT01792622
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Start: 2013-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase I Patient Interviews	Interview	Indepth interviews will be completed with approximately 15 patients.
Phase II Patient Questionnaire	Questionnaire	Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I

Primary Outcome Measures

Name	Time	Method
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.