Transitional ePRO Diary Liver (Transitional-ePRO)

NCT06342557 | Recruiting

• 1 other identifier: Transitional-ePRO
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (1)

ASST-Papa Giovanni XXIII

Bergamo, MILANO, 24127, Italy

RECRUITING

Study Officials

• Stefano Fagiuoli, MD

  ASST-PG23

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Giani, BS

CONTACT

035.2675134; gastroenterologia.liver@asstpg23.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): February 21, 2034
• Study Completion (Estimated): February 21, 2034
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)