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Behavioral Intervention
Electronic Quality of Life Reporting for Post-Pediatric Liver Transplant (SPaRO Trial)
N/A
Waitlist Available
Led By Eyal Shemesh, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a smartphone application/web interface to collect reports of a pediatric liver transplant recipient's quality of life from the child and parent, in order to evaluate how well the application can help integrate these evaluations into care.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves answering questionnaires through an app or web interface, there are no direct physical side effects like you'd expect with medication. However, participants may experience stress or discomfort while reflecting on their quality of life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Implementation metric
Medication level variability index (MLVI)
Patient baseline quality of life (child report on PeLTQL)
+3 moreOther study objectives
Rejection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pediatric liver transplant recipientsExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiOTHER
914 Previous Clinical Trials
570,677 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
712 Previous Clinical Trials
6,959,597 Total Patients Enrolled
Emory-Children's CenterOTHER
4 Previous Clinical Trials
5,000,488 Total Patients Enrolled
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,768,779 Total Patients Enrolled
Seattle Children's HospitalOTHER
310 Previous Clinical Trials
5,231,378 Total Patients Enrolled
University of San FranciscoOTHER
9 Previous Clinical Trials
1,081 Total Patients Enrolled
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,784 Total Patients Enrolled
Eyal Shemesh, MDPrincipal InvestigatorIcahn School of Medicine at Mt. Sinai
8 Previous Clinical Trials
909 Total Patients Enrolled
George Mazariegos, MDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study procedures and can explain them.I, and at least one guardian, can understand and discuss the study in English or Spanish.I am older than 8 and will be younger than 20 two years after joining.I had a liver transplant more than a year ago.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pediatric liver transplant recipients