Patient Reported Outcomes in Pulmonary Arterial Hypertension

NCT01792622

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with non-PAH Pulmonary Hypertension


- Physical inability to complete the interview process


- Subjects who are currently enrolled in an experimental drug study

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Advanced Information
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 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 and older   (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
Study Sponsor Pfizer
Collaborators
  • University of Chicago
  • Mayo Clinic
  • Vanderbilt University
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2013