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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02247934

Enrollment

Registered

2014-09-25

Start date

2014-10-31

Completion date

2015-10-31

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis

Keywords

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 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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire	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.

Countries

United States

Outcome results