Electronic Quality of Life Reporting for Post-Pediatric Liver Transplant

(SPaRO Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a smartphone app can gather information about the quality of life for children who have had a liver transplant. The goal is to determine if the app facilitates the inclusion of quality of life reports in their ongoing care. It focuses on children who received a liver transplant more than a year ago and continue treatment at the same medical center. Participants need internet access and a parent or guardian who can communicate in English or Spanish. The trial aims to enhance healthcare providers' understanding and support of these children's daily lives after their transplant. As an unphased trial, it offers participants a unique opportunity to contribute to innovative approaches in post-transplant care.

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 prior data suggests that this electronic quality of life reporting method is safe for pediatric liver transplant recipients?

Past studies have used the Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire to understand the quality of life for children who have had liver transplants. This questionnaire is now available on electronic devices like smartphones and tablets. Research has shown that the electronic version performs as well as the paper version. Since the study focuses on the questionnaire's use, there is no risk from the treatment itself. The main goal is to evaluate how effectively the technology collects quality of life data. No negative effects have been reported from using the electronic version of the questionnaire. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve the quality of life for pediatric liver transplant recipients through electronic means. Unlike traditional follow-ups that rely heavily on in-person visits and paper-based assessments, this trial uses the PeLTQL delivered electronically, allowing for more frequent and convenient reporting. This approach can potentially lead to more timely interventions and adjustments in care, ultimately enhancing the well-being of young transplant patients.

What evidence suggests that this electronic quality of life reporting is effective for post-pediatric liver transplant care?

Research has shown that the Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire effectively assesses children's well-being after a liver transplant. This trial will deliver the PeLTQL to participants electronically. Studies have found that digital tools, such as smartphone apps, can make care more efficient and provide immediate feedback. Recent data indicates that outcomes for children with liver transplants have improved, with a 90% chance of the transplant functioning well for at least one year and an 82% chance for at least five years. These improved long-term results suggest that digital methods might help maintain and even enhance these positive trends by tracking quality of life more effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Eyal Shemesh, MD

Principal Investigator

Icahn School of Medicine at Mt. Sinai

George Mazariegos, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05241847

NCT05241847 | Starzl Network Patient Reported Outcomes The QOL measure that is used in this study is the Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire. Utilization, effectiveness, and efficiency ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573715/

and 30-Year Outcomes for Pediatric Liver Transplant ... Recent registry data indicate 90% 1-year graft survival and 82% 5-year graft survival for pediatric LT recipients (1). These outcomes have steadily improved ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11235375/

Long-Term Cognitive Outcomes and Associated Quality of ... We evaluated long term outcomes in infants born between 1992 and 2002 with cholestatic liver disease (CLD) who underwent successful liver transplantation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949711623000783

Results of 950 pediatric liver transplants: prognostic factors ... During the last 20 years, the results of pediatric LT have improved significantly worldwide, pushed by the progress made in pre- and post-transplant care, and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/petr.70195

Share Seamlessly, Steal Shamelessly: Unlocking the ... We will present data on intra-operative flow rates in technical variant pediatric liver transplantation, including measurement distribution and ...

6. sickkids.ca sickkids.ca/en/care-services/clinical-departments/gastroenterology-hepatology-nutrition/paediatric-liver-transplant-quality-of-life/

Liver Transplant Quality of Life - The PeLTQL Questionnaire The PeLTQL questionnaire is designed to accurately assess early health-related quality of life (HRQOL) among paediatric liver transplant recipients.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36940170/

A patient-reported outcome measure for children and teens Equivalence of the adapted electronic Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire: A patient-reported outcome measure ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522084465

Outcomes following liver transplantation in young infants Our assessed primary outcomes were patient and graft survival post liver transplantation in children aged 0 to <3, 3 to <6, 6 months to <1 year, and 1 to 3 ...

9. mdpi.com mdpi.com/2075-4418/11/1/111

Health-Related Quality of Life 10 Years after Liver ... This was a longitudinal review examining HRQOL measured by Pediatric Liver Transplant Quality of Life (PeLTQL) in children between 8-17 years who underwent LTx.