Transitional ePRO Diary Liver

NCT ID: NCT06342557

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-28

Study Completion Date

2034-02-21

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Fagiuoli, MD

Role: PRINCIPAL_INVESTIGATOR

ASST-PG23

Locations

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ASST-Papa Giovanni XXIII

Bergamo, MILANO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pietro Giani, BS

Role: CONTACT

035.2675134

Facility Contacts

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Stefano Fagiuoli, MD

Role: primary

035.2674259

Other Identifiers

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FROM

Identifier Type: -

Identifier Source: org_study_id

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