Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)

February 8, 2016 updated by: Gilead Sciences
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.

Study Overview

Status

Completed

Conditions

Detailed Description

In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to:

  1. Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and
  2. Assess whether these symptoms impact day-to-day functioning

An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital, Denver Health Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Evidera
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Organ Care Research Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from approximately 5 clinical sites based in the United States.

Description

Inclusion Criteria:

  • Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening
  • Patient report of PSC symptoms associated with PSC diagnosis
  • Able to speak, read, and understand English
  • Willing and able to provide written informed consent to participate in the research study

Exclusion Criteria:

  • Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis
  • Patient with history of liver cirrhosis
  • Patients with history of cholangiocarcinoma
  • Patients who have received a liver transplant
  • Patients currently enrolled in PSC clinical trials; and
  • STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Concept elicitation interviews (Step I)
Approximately 20 participants will be included.
Cognitive interviews (Step II)
Approximately 30 participants will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
Time Frame: Up to 12 months
Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Rob Myers, MD, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-13601-000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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