Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)

Viatris

Status: Withdrawn

Conditions: Pulmonary Arterial Hypertension

Treatments: Other: Interview; Other: Questionnaire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01792622

A1481296

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Phase I Patient Interviews

Description:

Indepth interviews will be completed with approximately 15 patients.

Treatment:

Other: Interview

Phase II Patient Questionnaire

Description:

Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I

Treatment:

Other: Questionnaire