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Clinical Trials/NCT06342557
NCT06342557
Recruiting
Not Applicable

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

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS1 site in 1 country250 target enrollmentMarch 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Transplant
Sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Enrollment
250
Locations
1
Primary Endpoint
four-item Morisky Medication Adherence Scale (MGLS)
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2024
End Date
February 21, 2034
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

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 Sites (1)

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