Electronic Quality of Life Reporting for Post-Pediatric Liver Transplant

(SPaRO Trial)

Recruiting at 6 trial locations

Overseen By Daniel W Pieratt

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Transitioning services, comprehension issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

202 Participants Needed

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on using a smartphone app to report quality of life, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment PeLTQL delivery via electronic means for post-pediatric liver transplant patients?

The Pediatric Liver Transplantation Quality of Life (PeLTQL) tool has been validated as a disease-specific measure to assess the quality of life in children who have undergone liver transplants, helping to identify challenges they face. This tool, when used alongside other quality of life assessments, provides a more comprehensive understanding of the health-related quality of life in these patients, which is crucial for improving their overall care. ^{1 2 3 4 5}

Is electronic quality of life reporting safe for children after liver transplant?

The studies reviewed focus on the quality of life after pediatric liver transplantation and the tools used to measure it, but they do not provide specific safety data related to electronic quality of life reporting. ^{1 2 3 4 6}

How is the PeLTQL electronic reporting treatment different from other treatments for post-pediatric liver transplant patients?

The PeLTQL electronic reporting treatment is unique because it focuses on improving the quality of life for pediatric liver transplant recipients by using a disease-specific questionnaire delivered electronically, which helps identify and address specific challenges these patients face, unlike traditional treatments that may not focus on quality of life aspects. ^{1 2 3 4 7}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the RTC app-based tool to obtain PeLTQL scores from pediatric liver transplant recipients and their caregivers

12 months

Regular app-based assessments

Follow-up

Participants are monitored for quality of life and medication adherence post-implementation

12 months

Long-term Follow-up

Evaluation of long-term outcomes such as incidence of liver rejection and sustained quality of life improvements

24 months

Treatment Details

Interventions

• PeLTQL delivery via electronic means

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+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Emory-Children's Center

Collaborator

Trials

5

Recruited

5,001,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

University of San Francisco

Collaborator

Trials

10

Recruited

1,300+

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Health-related quality of life in pre-adolescent liver transplant recipients with biliary atresia: A cross-sectional study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Health-related quality of life after pediatric liver transplantation: A systematic review. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Measurement of health-related quality of life in pediatric organ transplantation recipients: a systematic review of the PedsQL transplant module. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Health-related quality of life in pediatric liver transplant recipients: A single-center study. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Liver transplant and quality of life in the pediatric population: a review update (2013-2014). [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Measuring quality of life in children and young people after transplantation: methodological considerations. [2015]