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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This study has been withdrawn prior to enrollment.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

February 7, 2013
July 31, 2013
July 2013
September 2013   (final data collection date for primary outcome measure)
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.

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 ]
Complete list of historical versions of study NCT01792622 on ClinicalTrials.gov Archive Site
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Patient Reported Outcomes in Pulmonary Arterial Hypertension
Patient Reported Outcomes in Pulmonary Arterial Hypertension

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

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with pulmonary arterial hypertension

Pulmonary Arterial Hypertension
  • 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.
  • 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.
  • Phase I Patient Interviews
    Indepth interviews will be completed with approximately 15 patients.
    Intervention: Other: Interview
  • 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
    Intervention: Other: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01792622
A1481296
No
Pfizer
Pfizer
  • University of Chicago
  • Mayo Clinic
  • Vanderbilt University
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP