NCT02712736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2018

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

March 11, 2016

Last Update Submit

January 28, 2020

Conditions

Primary Sclerosing Cholangitis

Keywords

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

  • Impaired quality of life as measured by questionnaire

    Approximately 2 weeks

Study Arms (1)

Survey respondents

OTHER

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

Interventions

quality of life surveyOTHER

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

Survey respondents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Andrew Muir, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 18, 2016

Study Start

July 1, 2016

Primary Completion

September 22, 2018

Study Completion

September 22, 2018

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)