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Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)

This study is not yet open for participant recruitment.
Verified May 2013 by Pfizer
Sponsor:
Collaborators:
University of Chicago
Mayo Clinic
Vanderbilt University
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01792622
First received: February 7, 2013
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Pulmonary Arterial Hypertension
 Other: Interview
Other: Questionnaire

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Patient Reported Outcomes in Pulmonary Arterial Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint for the study will be a composite symptom score derived from items in the instrument. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I Patient Interviews
Indepth interviews will be completed with approximately 15 patients.
 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.
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
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with pulmonary arterial hypertension

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792622

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer
University of Chicago
Mayo Clinic
Vanderbilt University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01792622     History of Changes
Other Study ID Numbers: A1481296
Study First Received: February 7, 2013
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Instrument Development
Patient Reported Outcomes
Pulmonary Arterial Hypertension.

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013