Effectiveness of SMS Reminders on Influenza Vaccination Coverage in Patients With RA in the ART Registry

Rheumatoid Arthritis Clinical Trial

Official title: Impact of an SMS Reminder on Influenza Vaccination Coverage in Patients With Rheumatoid Arthritis Taking Anti-TNF : an Ancillary Study to the French National Registry ART E-cohort

Status Completed

Clinical Trial Summary

Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. Therefore, when initiating anti-TNF treatments, it is recommended to update the vaccination schedule of these patients, to vaccinate them against pneumococcus and carry out an annual anti influenza vaccination.. However, vaccination coverage remains sub-optimal. The means to improve this vaccination coverage are multiple but often require human resources. Medical teams often lack time, nursing interventions are effective but again requires the availability of the health care team. The use of modern digital means (automatic reminders) is an attractive alternative to increase immunization coverage without the use of medical or paramedical time.

The objective of the study is to evaluate the effectiveness, in terms of immunization coverage, of SMS and/or email reminders reminding the need to vaccinate against seasonal influenza compared to usual care, in patients with RA on biotherapies participating in the e-cohort of the French ART Registry (NCT03062865).

This study will be based on the ART Registry e-cohort. This will be a randomized controlled trial in patients in the ART e-cohort. The patients will be allocated in one of the 2 arms : one arm receiving reminders by email and SMS of the influenza vaccination, the other arm with absence of reminders. This study will be conducted during the annual French National communication campaign to encourage influenza vaccination.

The main evaluation criterion will be the influenza vaccination coverage rate at the end of the vaccination campaign. It will be compared between the two arms.

Clinical Trial Description

Design :

Randomised, controlled trial within the e-cohort population of the French ART registry (observational study)

Target population :

All participants to the e-cohort of the French ART Registry (Rheumatoid Arthritis and anti-TNF) ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Influenza, Human
• Rheumatoid Arthritis

• NCT number: NCT05220423
• Study type: Interventional
• Source: Societe Francaise de Rhumatologie
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Completion date: April 30, 2022