Transitional ePRO Diary Liver (Transitional-ePRO) (MACROLIVER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Pietro Giani, BS; Phone Number: 035.2675134; Email: gastroenterologia.liver@asstpg23.it

Study Locations

• Italy
  • MILANO
    • Bergamo, MILANO, Italy, 24127
      • Recruiting
      • ASST-Papa Giovanni XXIII
      • Contact: Stefano Fagiuoli, MD; Phone Number: 035.2674259; Email: sfagiuoli@asst-pg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
four-item Morisky Medication Adherence Scale (MGLS)	MGLS is used to assess non-adherence to therapy. The MGLS includes four questions with yes/no response options, resulting in a score from 0 to 4. Based on this score, there are 3 levels of adherence: high, medium and low adherence with 0, 1-2 and 3-4 points respectively. Scores below 2 indicate a lack of adherence to therapy, while scores greater than or equal to 3 indicate adherence to therapy.	3 months

Collaborators and Investigators

• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
• Investigators: Principal Investigator: Stefano Fagiuoli, MD, ASST-PG23

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): February 21, 2034
• Study Completion (Estimated): February 21, 2034

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Transitional-ePRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No