Transitional ePRO Diary Liver

Liver Transplant Clinical Trial

— MACROLIVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342557
• Other study ID #: FROM
• Status: Recruiting
• Start date: March 28, 2024
• Est. completion date: February 21, 2034

Study information

• Verified date: April 2024
• Source: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
• Contact: Pietro Giani, BS
• Phone: 035.2675134
• Email: gastroenterologia.liver[@]asstpg23.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 21, 2034
• Est. primary completion date: February 21, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Liver Transplant

Locations

Country	Name	City	State
Italy	ASST-Papa Giovanni XXIII	Bergamo	Milano

Sponsors (1)

Lead Sponsor	Collaborator
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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