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

Societe Francaise de Rhumatologie

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: No reminders; Other: sms and emails reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT05220423

ART- Influenza

Details and patient eligibility

About

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.

Full 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)

Enrollment: 446 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All patients included in the French ART Registry (rheumatoid arthritis and anti-TNF) and participating to the e-cohort.

Inclusion Criteria:

• Adult patients with RA,
• Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
• Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription

Exclusion Criteria:

• Patient already treated by the same anti-TNF in the past (same drug)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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446 participants in 2 patient groups

Reminders Group

Other group

Description:

This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities

Treatment:

Other: sms and emails reminders

No reminders group

Other group

Description:

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

Treatment:

Other: No reminders