Liver Transplant; ComplicationsSPaRONCT05241847
Starzl Network Patient Reported Outcomes
A study testing PeLTQL delivery via electronic means in people with Liver Transplant; Complications and Quality of Life, run by University of Pittsburgh at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Liver Transplant; Complications, Quality of Life, Child Behavior
- What is being tested?
- PeLTQL delivery via electronic means
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 28 Feb 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patient must meet all of below criteria to be eligible for enrollment in the study:
- The patient is > 8 at enrollment and < 20 years of age at 2 year post enrollment.
- The patient received a liver transplantation at least 1 year prior to enrollment.
- The patient and parent/ guardian have internet access either through a smartphone, tablet or computer.
- The patient and at least one guardian speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
Who cannot join
- None of the following may be present if the patient is to be eligible for enrollment in the study:
- The patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment.
- The guardian or patient (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and adolescent to repeat the study procedures.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Emory Children's
Atlanta, Georgia, 30322
Columbia University Children's
New York, New York, 10027
Mt. Sinai
New York, New York, 10029
UCSF Benioff Children's Hospital
Oakland, California, 94609
UPMC Children's
Pittsburgh, Pennsylvania, 15224
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: Starzl Network for Excellence in Pediatric Transplantation (SNEPT) Implementation of a QoL Measure in Pediatric Transplant Recipients
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.
Read the detailed description
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.
- Being tested
- PeLTQL delivery via electronic means
- Keywords
- quality of life
- Medical subject headings
- Child Behavior, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeLTQL delivery via electronic meansBehavioural
Also called Real Time Clinic mobile application
Delivery of PeLTQL scoring information to clinicians via electronic means.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric liver transplant recipients | Experimental | 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. Receives: Behavioral: PeLTQL delivery via electronic means |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation metric
The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once
Measured: 12 months
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months post-enrollment
Medication level variability index (MLVI)
Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication.
Measured: 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
Measured: 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
Measured: Second administration of PeLTQL within 24 months
Implementation metric
Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start28 Feb 2022
- Primary completion20 Mar 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm interventional trial with use of the RTC mobile application representing the intervention of interest
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, The Hospital for Sick Children, Emory-Children's Center, Columbia University, Seattle Children's Hospital, University of San Francisco
- Responsible party
- Principal investigator, George Mazariegos, University of Pittsburgh
- Investigators
- Eyal Shemesh, MD, Principal investigator, Icahn School of Medicine at Mt. SinaiGeorge Mazariegos, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241847
- Sponsor's protocol ID
- STUDY21090139
- Other IDs
- U18HS028380-01
- Acronym
- SPaRO
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng V, Nicholas D, Dhawan A, Yazigi N, Ee L, Stormon M, Gilmour S, Schreiber R, Taylor R, Otley A; PeLTQL study group. Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients. J Pediatr. 2014 Sep;165(3):547-55.e7. doi: 10.1016/j.jpeds.2014.05.024. Epub 2014 Jun 26.
PubMed 24976329Ng VL, Kwan K, Logan S, Chessell J, Lobritto SJ, Hsu EK, Perito ER, Gupta NA, Dunphy C, Pieratt D, Kleinman LC, Shemesh E, Mazariegos GV. Minimal Clinically Important Difference for the PeLTQL in Pediatric Liver Transplantation: A Multicenter Analysis. Pediatr Transplant. 2026 May;30(4):e70320. doi: 10.1111/petr.70320.
PubMed 42010801
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starzl Network for Excellence in Pediatric Transplantation (SNEPT) Implementation of a QoL Measure in Pediatric Transplant Recipients
- ClinicalTrials.gov ID
- NCT05241847
- Acronym / sponsor ID
- SPaRO / STUDY21090139
- Keywords
- quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, The Hospital for Sick Children, Emory-Children's Center, Columbia University, Seattle Children's Hospital, University of San Francisco
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm interventional trial with use of the RTC mobile application representing the intervention of interest
| Arm | Type | Receives |
|---|---|---|
| Pediatric liver transplant recipients | Experimental | Behavioral: PeLTQL delivery via electronic meansAs 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 may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- The patient is > 8 at enrollment and < 20 years of age at 2 year post enrollment.
- The patient received a liver transplantation at least 1 year prior to enrollment.
- The patient and parent/ guardian have internet access either through a smartphone, tablet or computer.
- The patient and at least one guardian speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
Key exclusion criteria (3 listed)
- None of the following may be present if the patient is to be eligible for enrollment in the study:
- The patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment.
- The guardian or patient (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and adolescent to repeat the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeLTQL delivery via electronic meansAlso: Real Time Clinic mobile applicationDelivery of PeLTQL scoring information to clinicians via electronic means. | Behavioural | Pediatric liver transplant recipients |
Primary outcome
Implementation metric
Time frame: 12 months
The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once
9 secondary outcomes
Patient baseline quality of life (child report on PeLTQL)
Time frame: Time of enrollment
Patient quality of life (child report on PeLTQL)
Time frame: 12 months post-enrollment
Proxy report of child's quality of life using PeLTQL
Time frame: Time of enrollment
Proxy report of child's quality of life using PeLTQL
Time frame: 12 months post-enrollment
Medication level variability index (MLVI)
Time frame: Calculated for year following implementation (12 month period following enrollment)
PeLTQL discrepancy score
Time frame: First administration of PeLTQL in year 1
PeLTQL discrepancy score
Time frame: Second administration of PeLTQL within 24 months
Implementation metric
Time frame: 18 months
Implementation metric
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 24976329Ng V, Nicholas D, Dhawan A, Yazigi N, Ee L, Stormon M, Gilmour S, Schreiber R, Taylor R, Otley A; PeLTQL study group. Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients. J Pediatr. 2014 Sep;165(3):547-55.e7. doi: 10.1016/j.jpeds.2014.05.024. Epub 2014 Jun 26.
- Derived from this study: PubMed 42010801Ng VL, Kwan K, Logan S, Chessell J, Lobritto SJ, Hsu EK, Perito ER, Gupta NA, Dunphy C, Pieratt D, Kleinman LC, Shemesh E, Mazariegos GV. Minimal Clinically Important Difference for the PeLTQL in Pediatric Liver Transplantation: A Multicenter Analysis. Pediatr Transplant. 2026 May;30(4):e70320. doi: 10.1111/petr.70320.
- Starzl Network Main WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant; Complications
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Shemesh, MD principal investigator
Icahn School of Medicine at Mt. Sinai
George Mazariegos, MD principal investigator
University of Pittsburgh
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeLTQL delivery via electronic means in people with Liver Transplant; Complications and Quality of Life, run by University of Pittsburgh at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation metric (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.