Actively Recruiting

Age: 18Years +
All Genders
ID07442760

The Patient is the Main Protagonist of His Care Journey

Led by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Updated on 2026-03-02

55

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a digital tool designed to help patients with Delta hepatitis (HDV) and their caregivers manage liver disease more effectively. This condition is a severe form of viral hepatitis that rapidly progresses to serious liver damage or cancer, often requiring liver transplantation at a young age. The study is part of the MACROLIVER Project and addresses challenges such as limited screening, late diagnosis, and the need for better patient engagement, especially after the recent approval of a new antiviral drug. The study focuses on the ePro-Diary HDV, a mobile phone application that encourages continuous communication between patients and doctors. This app allows patients to monitor key laboratory results, complete quality of life questionnaires, and track overall health status remotely. The digital tool aims to increase patient involvement in their care and improve adherence to medical visits without replacing standard clinical monitoring. Participants will be followed for three years, during which researchers will measure the proportion of scheduled follow-up visits attended each year. The study will assess changes in patients' quality of life using this active remote approach. Throughout the trial, patient health data and questionnaire responses will be collected via the app to support clinicians and enhance patient care management.

CONDITIONS

Brief Title

ePro Diary - HDV ( MACROLIVER )

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Diagnosis of Delta infection (anti-HDV positivity)
  • Signed informed consent
  • Ability to adequately understand instructions for correctly using mobile device applications.
Not Eligible

You will not qualify if you...

  • Refusal or inability to provide informed consent.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - 3 years

Participants are monitored over time to observe their health status and disease progression.

Annual visits for 3 years

Trial Site Locations

Total: 1 location

1

ASST-Papa Giovanni XXIII

Bergamo, Italy, Italy, 24127

Actively Recruiting

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Research Team

P

Pietro Giani, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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