An interventional study of PeLTQL delivery via electronic means in Liver Transplant; Complications, Quality of Life and Child Behavior, sponsored by University of Pittsburgh. Completed at 7 sites in 2 countries. Open to participants aged 8 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
Despite evidence supporting the benefits of QOL assessments and the availability of many QOL assessment instruments, the integration of these instruments into clinical practice has not yet become standard of care.
The Pediatric Liver Transplant Quality of Life (PeLTQL), the study measure, is a condition-specific 26-item questionnaire; the investigators will be evaluating both total scores as well as subdomain scores and, importantly, discrepancies between child and parent reports of the child's QOL.
The Electronic Platform: Real-Time Clinic (RTC). The platform will furnish providers with the total scores, subscale scores, thresholds ("met" vs. "not met"), discrepancy scores, and any question that has scores which may concern the clinician/clinical team.
This information will be available before the clinic visit and can guide and inform discussion and problem-solving between patient and clinical team. The study does not standardize the response to the results and will not suggest a preferred way of action. Interpretation of the results, as well as actions related to them are completely left to clinician's discretion.
The setting of this study - the Starzl Network for Excellence in Pediatric Transplantation (SNEPT Centers). SNEPT is a learning healthcare network that was established in 2018 to accelerate improvement in transplant outcomes by incorporating innovation, technology and the patient voice to address gaps in care that were identified by the collaborative transplant centers and family representatives.
Study Aims
The primary aim is successful implementation of the RTC app-based tool to obtain PeLTQL scores from pediatric liver transplant recipients and their parents or caregivers.
The investigators also aim to assess the usability, impact, and ease of use (both for clinicians and patients/families) of the RTC platform and app-based version of the PeLTQL. The investigators will evaluate clinicians' subjective views on the platforms' ease of use, their time spent evaluating results, both in clinic and before patient visits, as well as the app's impact on back-end clinic workflow.
Impact on patient outcomes will be evaluated using pre-post comparisons on adherence (determined by the objective medication level variability index, MLVI) as well as on the PeLTQL.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's enrollment of 200 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
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The patient must meet all of below criteria to be eligible for enrollment in the study:
Exclusion Criteria:
None of the following may be present if the patient is to be eligible for enrollment in the study:
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
Delivery of PeLTQL scoring information to clinicians via electronic means.
Also known as: Real Time Clinic mobile application
Implementation metric
The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once
Time frame: 12 months
Patient baseline quality of life (child report on PeLTQL)
PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL
Time frame: Time of enrollment
Patient quality of life (child report on PeLTQL)
PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL
Time frame: 12 months post-enrollment
Proxy report of child's quality of life using PeLTQL
PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL
Time frame: Time of enrollment
Proxy report of child's quality of life using PeLTQL
PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL
Time frame: 12 months post-enrollment
Medication level variability index (MLVI)
Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication.
Time frame: Calculated for year following implementation (12 month period following enrollment)
PeLTQL discrepancy score
The discrepancy score is defined as the parent score minus the child's score on the PELTQL. PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire
Time frame: First administration of PeLTQL in year 1
PeLTQL discrepancy score
The discrepancy score is defined as the parent score minus the child's score on the PELTQL. PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire
Time frame: Second administration of PeLTQL within 24 months
Implementation metric
Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.
Time frame: 18 months
Implementation metric
Percentage of participating parent-child dyads (amongst all dyads) in which both the parent and the child completed one or more questionnaires during the study period.
Time frame: 24 months
Rejection
Incidence of rejection of the transplanted liver
Time frame: 24 months
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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