Menu
Recruiting NCT06342557

Transitional ePRO Diary Liver (Transitional-ePRO)

Observational Liver Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Transplant. Basic parameters: 14 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Integrated System for Patients Who Belong the Transition to Adult Services and Are Undergoing a Liver Transplant

Overview

The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients.

Primary outcome measures

  • four-item Morisky Medication Adherence Scale (MGLS) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • patients between the ages of 14 and 20 who have been transplanted at the ASST-PG23 transplant center or are awaiting a liver transplant and belong to the transition to adult services
  • signed informed consent
  • proven use of the APPs (to be assessed based on the last 2 weeks)

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • ASST-Papa Giovanni XXIII — Bergamo

Identifiers

NCT: NCT06342557 · Transitional-ePRO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗