Starzl Network Patient Reported Outcomes

NCT05241847 | Completed

• 2 other identifiers: STUDY21090139U18HS028380-01
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 7

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 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.

Conditions

Liver Transplant; Complications; Quality of Life; Adolescent Behavior; Child Behavior

Keywords

quality of life

Outcome Measures

Primary Outcomes (1)

• Implementation metric

  The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once

  12 months

Secondary Outcomes (9)

• Patient baseline quality of life (child report on PeLTQL)

  Time of enrollment

• Patient quality of life (child report on PeLTQL)

  12 months post-enrollment

• Proxy report of child's quality of life using PeLTQL

  Time of enrollment

• Proxy report of child's quality of life using PeLTQL

  12 months post-enrollment

• Medication level variability index (MLVI)

  Calculated for year following implementation (12 month period following enrollment)

Other Outcomes (1)

• Rejection

  24 months

Study Arms (1)

Pediatric liver transplant recipients

EXPERIMENTAL

As this is a single arm trial, all eligible liver transplant recipients and their caregivers will be enrolled in this arm. Eligible participants are children who received a liver transplant at least 1 year prior to enrollment at a participating SNEPT center and continue to receive their post-transplant care at that center.

Behavioral: PeLTQL delivery via electronic means

Interventions

PeLTQL delivery via electronic means BEHAVIORAL

Delivery of PeLTQL scoring information to clinicians via electronic means.

Also known as: Real Time Clinic mobile application

Pediatric liver transplant recipients

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: collaborator
• Emory-Children's Center: collaborator
• University of Pittsburgh: lead
• The Hospital for Sick Children: collaborator
• Columbia University: collaborator
• Seattle Children's Hospital: collaborator
• University of San Francisco: collaborator

Study Sites (7)

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Emory Children's

Atlanta, Georgia, 30322, United States

Location

Columbia University Children's

New York, New York, 10027, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

UPMC Children's

Pittsburgh, Pennsylvania, 15224, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

Toronto Sick Kids

Toronto, Ontario, 10001, Canada

Location

Related Publications (1)

• Ng V, Nicholas D, Dhawan A, Yazigi N, Ee L, Stormon M, Gilmour S, Schreiber R, Taylor R, Otley A; PeLTQL study group. Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients. J Pediatr. 2014 Sep;165(3):547-55.e7. doi: 10.1016/j.jpeds.2014.05.024. Epub 2014 Jun 26.

  PMID: 24976329 BACKGROUND

Related Links

• Starzl Network Main Website

MeSH Terms

Conditions

Child Behavior; Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eyal Shemesh, MD

  Icahn School of Medicine at Mt. Sinai

  PRINCIPAL INVESTIGATOR

• George Mazariegos, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Chief Pediatric Transplantation

Model Details: Single arm interventional trial with use of the RTC mobile application representing the intervention of interest

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 16, 2022
• Study Start: February 28, 2022
• Primary Completion: March 20, 2024
• Study Completion: July 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)