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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Gilead Sciences

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gilead Sciences

Dates:
Date Received: September 5, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016