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

Primary Purpose

Primary Sclerosing Cholangitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

quality of life survey

About this trial

This is an interventional other trial for Primary Sclerosing Cholangitis focused on measuring Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Survey respondents

Arm Description

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.

Outcomes

Primary Outcome Measures

Impaired quality of life as measured by questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT02712736

First Posted

March 11, 2016

Last Updated

January 28, 2020

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02712736

Brief Title

Quality of Life in Patients With Primary Sclerosing Cholangitis

Acronym

QOL in PSC

Official Title

Quality of Life in Primary Sclerosing Cholangitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

September 22, 2018 (Actual)

Study Completion Date

September 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis

Keywords

Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Survey respondents

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

quality of life survey

Intervention Description

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

Primary Outcome Measure Information:

Title

Impaired quality of life as measured by questionnaire

Time Frame

Approximately 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Muir, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Quality of Life in Patients With Primary Sclerosing Cholangitis

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