ePro Diary for people with HDV (MACROLIVER)
The Patient is the Main Protagonist of His Care Journey
This project will try a mobile ePro diary app to help adults with Delta hepatitis (HDV) track symptoms and share health information with their care team.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 1 site (Bergamo, Italy) |
| Trial ID | NCT07442760 on ClinicalTrials.gov |
What this trial studies
This observational project within the MACROLIVER initiative aims to develop a digital tool (an electronic patient-reported outcomes diary) for patients with HDV and their caregivers. Adults with confirmed anti-HDV positivity will be asked to use a mobile application to record symptoms, medications, and other relevant health data with informed consent. The study collects real-world patient-reported information to characterize symptom patterns, disease impact, and app usability in routine care. Data are collected at ASST-Papa Giovanni XXIII in Bergamo, Italy, and will inform further tool development and wider implementation strategies.
Who should consider this trial
Good fit: Adults (over 18) with confirmed Delta infection (anti-HDV positive) who can use a smartphone or tablet and provide informed consent.
Not a fit: People who are not HDV-positive, who cannot or will not use mobile device apps, or who cannot give informed consent are unlikely to benefit.
Why it matters
Potential benefit: If successful, the ePro diary could help patients and clinicians detect symptom changes earlier and improve day-to-day disease management.
How similar studies have performed: Electronic symptom diaries and ePRO tools have improved symptom monitoring in other chronic liver diseases and viral hepatitis, but dedicated ePRO work for HDV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Diagnosis of Delta infection (anti-HDV positivity) * Signed informed consent * Ability to adequately understand instructions for correctly using mobile device applications. Exclusion Criteria: * Refusal or inability to provide informed consent.
Where this trial is running
Bergamo, Italy
- ASST-Papa Giovanni XXIII — Bergamo, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Pietro Giani, BS
- Email: gastroenterologia.liver@asstpg23.it
- Phone: 035 2675134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.