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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06342557
Other study ID # FROM
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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