CompletedNot Applicable

Starzl Network Patient Reported Outcomes

United States200 participantsStarted 2022-02-28

Plain-language 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 extent to which QOL evaluations can be integrated into care with the help of the application. The QOL measure that is used in this study is the Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire. Utilization, effectiveness, and efficiency data are evaluated. Hypotheses are fully described in the protocol. The primary hypothesis is that 80% of recruited child-proxy dyads will have at least one RTC-enabled PeLTQL score at 12 months. Other hypotheses look at implementation metrics and patient outcomes.

Who can participate

Age range8 Years – 20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Implementation metric

Timeframe: 12 months

Trial details

NCT IDNCT05241847

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-20

View on ClinicalTrials.gov More Liver Transplant; Complications trials