Quality of Life in Patients With Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

— QOL in PSC  

Official title:

Quality of Life in Primary Sclerosing Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712736
• Other study ID #: Pro00069683
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: September 22, 2018

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and alternative medicine use in patients with PSC.

Description:

A cohort of adult (age ≥ 18) patients with a diagnosis of PSC will be identified. The patients will be approached about participating in the study while at their appointment, either by the investigators or someone else known to the patient. If the patient agrees, the investigators or other key personnel will then provide information about the study and obtain their informed consent to participate.

The patients who consent to participate will be sent home from the clinic with a survey to complete and return via mail in a provided addressed, stamped envelope. The survey consists of the Short Form-36 (SF-36), the Chronic Liver Disease Questionnaire (CLDQ), questions from the PROMIS SexFs v2.0, questions regarding perceived risk for liver transplant, cholangiocarcinoma, and colorectal carcinoma, as well as perceived overall life expectancy, and questions regarding complementary and alternative medicine use.

Demographic information and clinical data will also be obtained from the patient's electronic medical record. The study will be cross-sectional in nature, and there will be no follow-up with the subjects after the survey is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 22, 2018
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (age = 18) patients with PSC, confirmed by laboratory tests, imaging, and/or liver biopsy

Exclusion Criteria:

• Patients <18

• Patients who have undergone liver transplant, patients with frank hepatic encephalopathy

• Patients with active inflammatory bowel disease (IBD) flares

• Patients with malignancies

• Patients unable to understand English

• Patients refusing to participate or provide informed consent

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Other:
• quality of life survey
subjects with PSC will be administered a survey to assess their quality of life

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impaired quality of life as measured by questionnaire		Approximately 2 weeks