We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life in Patients With Primary Sclerosing Cholangitis (QOL in PSC)

This study is currently recruiting participants.
Verified February 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02712736
First Posted: March 18, 2016
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Primary Sclerosing Cholangitis Other: quality of life survey

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Quality of Life in Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Impaired quality of life as measured by questionnaire [ Time Frame: Approximately 2 weeks ]

Estimated Enrollment: 250
Actual Study Start Date: July 1, 2016
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Survey respondents
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.
Other: quality of life survey
subjects with PSC will be administered a survey to assess their quality of life

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712736


Contacts
Contact: Andrew Muir, MD 919-684-2052 andrew.muir@duke.edu

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Andrew Muir, MD    919-684-2052    andrew.muir@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Muir, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02712736     History of Changes
Other Study ID Numbers: Pro00069683
First Submitted: March 11, 2016
First Posted: March 18, 2016
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
Primary Sclerosing Cholangitis

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases