Status:
COMPLETED
Starzl Network Patient Reported Outcomes
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
The Hospital for Sick Children
Conditions:
Liver Transplant; Complications
Quality of Life
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief Summary
This study uses a smartphone application/web interface (RealTime Clinic; RTC) to collect patient and parent reports of a pediatric liver transplant recipient's quality of life (QOL), and examines the ...
Detailed Description
Despite evidence supporting the benefits of QOL assessments and the availability of many QOL assessment instruments, the integration of these instruments into clinical practice has not yet become stan...
Eligibility Criteria
Inclusion
- The patient must meet all of below criteria to be eligible for enrollment in the study:
- The patient is \> 8 at enrollment and \< 20 years of age at 2 year post enrollment.
- The patient received a liver transplantation at least 1 year prior to enrollment.
- The patient and parent/ guardian have internet access either through a smartphone, tablet or computer.
- The patient and at least one guardian speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
Exclusion
- None of the following may be present if the patient is to be eligible for enrollment in the study:
- The patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment.
- The guardian or patient (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and adolescent to repeat the study procedures.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05241847
Start Date
February 28 2022
End Date
July 30 2025
Last Update
January 8 2026
Active Locations (7)
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1
UCSF Benioff Children's Hospital
Oakland, California, United States, 94609
2
Emory Children's
Atlanta, Georgia, United States, 30322
3
Columbia University Children's
New York, New York, United States, 10027
4
Mt. Sinai
New York, New York, United States, 10029