Patient Reported Outcomes in Pulmonary Arterial Hypertension

NCT ID: NCT01792622

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase I Patient Interviews

Indepth interviews will be completed with approximately 15 patients.

Interview

Intervention Type OTHER

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.

Phase II Patient Questionnaire

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

Questionnaire

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Chicago

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A1481296

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Novel Index (PIMR) in PAH
NCT05812976 COMPLETED
Neuromodulation in Patients With Pulmonary Arterial Hypertension
NCT06802380 NOT_YET_RECRUITING PHASE1/PHASE2
PAH Exercise Study
NCT06941441 RECRUITING PHASE3