Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)

This study has been withdrawn prior to enrollment.
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: July 31, 2013
Last verified: July 2013
  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:


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 ]

    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.



Enrollment: 0
Study Start Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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: July 31, 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 August 20, 2014