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Trial record 1 of 1 for:    NCT01792622
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Patient Reported Outcomes in Pulmonary Arterial Hypertension (PROPAH)

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ClinicalTrials.gov Identifier: NCT01792622
Recruitment Status : Withdrawn
First Posted : February 15, 2013
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
University of Chicago
Mayo Clinic
Vanderbilt University
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date February 7, 2013
First Posted Date February 15, 2013
Last Update Posted Date January 28, 2021
Study Start Date July 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2013)
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. ]
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.
Original Primary Outcome Measures
 (submitted: February 13, 2013)
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. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Reported Outcomes in Pulmonary Arterial Hypertension
Official Title Patient Reported Outcomes in Pulmonary Arterial Hypertension
Brief Summary Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with pulmonary arterial hypertension
Condition Pulmonary Arterial Hypertension
Intervention
  • 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.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: July 31, 2013)
0
Original Estimated Enrollment
 (submitted: February 13, 2013)
220
Estimated Study Completion Date September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01792622
Other Study ID Numbers A1481296
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
  • University of Chicago
  • Mayo Clinic
  • Vanderbilt University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021