NCT06127563 Caring for Frail Patients Through Vaccination
| NCT ID | NCT06127563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Vaccination Uptake |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-07-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-07-17 with a primary completion date of 2026-07-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The CareVax project aims to find frail patients at Fondazione Policlinico Universitario 'A. Gemelli' IRCCS who could benefit from vaccinations against pneumococcal, Zoster, flu, HBV and SARS-CoV-2. This will reduce hospital stays, long-term effects, and deaths related to these diseases, as outlined in the PNPV (National Plan for Vaccine Prevention) 2017-2019 and Ministry of Health circulars from September, October, December 2022, and January 2023. Eligible patients, upon consent, will be identified by applying an automated algorithm to the patient's electronic health record and vaccination history contained in the regional vaccination registry. Identified patients will be contacted either directly if they are admitted to the inpatient wards of the Fondazione Policlinico Universitario "A.Gemelli" IRCCS (FPG) Hospital, or by messaging or e-mail in the case of access to the FPG for follow-up or routine visits or day hospital or day surgery service. Patients contacted, depending on their frail condition, will be booked for vaccination at an hospital vaccine clinic (extremely vulnerable patients) or a Local Health Unit (ASL Roma1) vaccine clinic respectively (frail patients). The project envisages a validation phase of the algorithm, through the evaluation of its concordance with the judgement of a blinded clinician on a small group of patients Patients' engagement and a proper communication system with them will be carried through an interoperable digital system aimed at booking the new vaccination appointment, reminding it and providing patients with all the information needed.
Eligibility Criteria
Inclusion Criteria: * 18 years old or more, * Patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology), * Medical residence in Lazio Region Exclusion Criteria: \- Patients who do not fulfill 1 or more inclusion criteria
Contact & Investigator
Patrizia Laurenti
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06127563 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vaccination Uptake. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06127563 currently recruiting?
Yes, NCT06127563 is actively recruiting participants. Contact the research team at patrizia.laurenti@policlinicogemelli.it for enrollment information.
Where is the NCT06127563 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06127563 clinical trial?
NCT06127563 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Patrizia Laurenti at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 1,500 participants.