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

NCT05220423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

Interventions

OTHER

sms and emails reminders

6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities

OTHER

No reminders

no reminders on top of the National annual communication campaign organized by the French Health System authorities

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • University Hospital, Toulouse

    collaborator OTHER
  • Societe Francaise de Rhumatologie

    lead OTHER

Principal Investigators

  • Raphaele Seror · Hôpital Bicêtre

  • Adeline Ruyssen-Witrand · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220423 on ClinicalTrials.gov