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Recruiting

NCT Number: NCT06342557

Transitional ePRO Diary Liver (Transitional-ePRO)

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.

Recruiting

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Key information

Conditions

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST-Papa Giovanni XXIII

Bergamo, MILANO, 24127, Italy

Location status: Recruiting

Location contact

Stefano Fagiuoli, MD

CONTACT

[email protected]

035.2674259

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. four-item Morisky Medication Adherence Scale (MGLS)

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pietro Giani, BS

CONTACT

[email protected]

035.2675134

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

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

Acronym: MACROLIVER

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Apr 2, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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