Electronic Quality of Life Reporting for Post-Pediatric Liver Transplant

(SPaRO Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by George Mazariegos, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pittsburgh

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eyal Shemesh, MD

Principal Investigator

Icahn School of Medicine at Mt. Sinai

George Mazariegos, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for pediatric liver transplant recipients aged over 8 and under 20 years, who had their transplant at least a year ago. They must speak English or Spanish well enough to understand the study and have internet access. It's not for those planning to change medical services within a year.

Inclusion Criteria

I, and at least one guardian, can understand and discuss the study in English or Spanish.

Patient and parent/guardian have internet access through a smartphone, tablet, or computer

I am older than 8 and will be younger than 20 two years after joining.

Exclusion Criteria

Patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment

I understand the study procedures and can explain them.

Treatment Details

Interventions

• PeLTQL delivery via electronic means (Behavioral Intervention)

Trial Overview The study tests how well a smartphone app/web interface can collect quality of life reports from kids with liver transplants and their parents. The goal is to see if these reports can help improve care by using the Pediatric Liver Transplant Quality of Life questionnaire.

Participant Groups

Group I: Pediatric liver transplant recipients Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Emory-Children's Center

Collaborator

Trials

5

Recruited

5,001,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Dr. Jeff Sperring

Seattle Children's Hospital

Chief Executive Officer since 2015

MD from Indiana University School of Medicine

Dr. Jeff Ojemann

Seattle Children's Hospital

Chief Medical Officer since 2022

MD from Washington University in St. Louis

University of San Francisco

Collaborator

Trials

10

Recruited

1,300+