AzTrials
AzTrials

Vaccination UptakeCAREVAXNCT06127563

Caring for Frail Patients Through Vaccination

An observational study of Vaccination Uptake, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vaccination Uptake
What is being tested?
creation of a clinical pathway to increase vaccination coverage in frail patients
Type of treatment
Vaccines
How many people
1,500 participants
Where
1 siteItaly
Study dates
17 Jul 2024to 17 Jul 2027
How long will I take part?
4 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of adult patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology) of teaching hospital A. Gemelli and whose sanitary residence is in Lazio Region (This criteria was inserted because as of now the italian digital infrastructure of the vaccination registry allows easy access only for Regional data) .

Who may be able to join

  • 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

Who cannot join

  • Patients who do not fulfill 1 or more inclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patrizia Laurenti contact

+390630155701

patrizia.laurenti@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, Lazio, 00168

    Patrizia Laurenti, +390630155701, patrizia.laurenti@policlinicogemelli.it

    Patrizia Laurenti

    Recruiting

Other trials in Italy

About this study

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.

Being tested
creation of a clinical pathway to increase vaccination coverage in frail patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • creation of a clinical pathway to increase vaccination coverage in frail patientsOther

    creation of a clinical pathway to increase vaccination coverage for frail patients, integrating hospital and local health units through an automated algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccinated against influenza at 24 months

    Proportion of participants vaccinated against influenza 24 months after the beginning of the study

    Measured: 24 months

  2. Vaccinated against influenza at 12 months

    Proportion of participants vaccinated against influenza 12 months after the beginning of the study

    Measured: 12 months

  3. Vaccinated against influenza at 6 months

    Proportion of participants vaccinated against influenza 6 months after the beginning of the study

    Measured: 6 months

  4. Vaccinated against COVID19 at 24 months

    Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study

    Measured: 24 months

  5. Vaccinated against COVID19 at 12 months

    Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study

    Measured: 12 months

  6. Vaccinated against COVID19 at 6 months

    Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study

    Measured: 6 months

  7. Algorithm clinician concordance - initial sample of patients

    Concordance between the clinician's and the algorithm's judgments on patient eligibility for vaccination, measured on a sample of patients.

    Measured: At the start

  8. Algorithm clinician concordance

    The proportion of vaccinations confirmed by physicians compared to those proposed by the algorithm.

    Measured: 24 months

  9. Feasibility in reaching the patients

    Number of patients successfully contacted to offer a vaccination appointment after being considered eligible compared to the number of patients flagged by the algorithm.

    Measured: 24 months

  10. Acceptability of the vaccination offer

    Number of patients consenting to vaccination appointments compared to the number of patients contacted.

    Measured: 24 months

  11. Logistical feasibility of the vaccination pathway

    Number of patients presenting to vaccination centers (Hospital or Local Health Authority) compared to the number who have booked a vaccination appointment.

    Measured: 24 months

  12. Patients' drop out proportion

    Number of patients who drop out or are lost to follow-up versus the total number of patients recruited.

    Measured: 24 months

Secondary outcomes (10)

  1. Vaccinated against Hepatitis B virus at 24 months

    Proportion of participants vaccinated against Hepatitis B virus 24 months after the beginning of the study

    Measured: 24 months

  2. Vaccinated against Herpes Zoster virus at 24 months

    Proportion of participants vaccinated against Herpes Zoster virus 24 months after the beginning of the study

    Measured: 24 months

  3. Vaccinated against Pneumococcus at 24 months

    Proportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study

    Measured: 24 months

  4. Vaccinated against Hepatitis B virus at 12 months

    Proportion of participants vaccinated against Hepatitis B virus 12 months after the beginning of the study

    Measured: 12 months

  5. Vaccinated against Herpes Zoster virus at 12 months

    Proportion of participants vaccinated against Herpes Zoster virus 12 months after the beginning of the study

    Measured: 12 months

  6. Vaccinated against Pneumococcus at 12 months

    Proportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study

    Measured: 12 months

  7. Vaccinated against Hepatitis B virus at 6 months

    Proportion of participants vaccinated against Hepatitis B virus 6 months after the beginning of the study

    Measured: 6 months

  8. Vaccinated against Herpes Zoster virus at 6 months

    Proportion of participants vaccinated against Herpes Zoster virus 6 months after the beginning of the study

    Measured: 6 months

  9. Vaccinated against Pneumococcus at 6 months

    Proportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study

    Measured: 6 months

  10. Alerts generated by the algorithm at 24 months

    Number of vaccination alerts generated by the algorithm among the study participants in the first 24 months after the beginning of the study

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start17 Jul 2024
  3. Primary completion17 Jul 2026 (estimated)
  4. Study completion17 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127563
Sponsor's protocol ID
5819
Acronym
CAREVAX
Status last verified
Jul 2025
First submitted
12 Jun 2023
Last updated
12 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lontano A, Regazzi L, Tona DM, Di Pumpo M, Porcelli M, Cacciuttolo MG, Parente P, Gasbarrini A, Grandaliano G, Panocchia N, Lopetuso L, Pasciuto T, Cadeddu C, Bruno S, Laurenti P, Pascucci D, Pastorino R. Digital integration between hospitals and local health authorities for enhanced vaccination coverage among frail patients: the CareVax study protocol. Front Public Health. 2025 Jan 30;13:1490244. doi: 10.3389/fpubh.2025.1490244. eCollection 2025.

    PubMed 39949559

Questions about this trial

What is this clinical trial studying?

An observational study of Vaccination Uptake, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrizia Laurenti (+390630155701, patrizia.laurenti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccinated against influenza at 24 months (time frame: 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127563, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in