Clinical trial NCT05220423: Effectiveness of SMS Reminders on Influenza Vaccination Coverage in Patients With RA in the ART Registry
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: anti-TNF
Flu
influenza
vaccination
biologics
bDMARDs
targeted therapies
Lead sponsor: Societe Francaise de Rhumatologie
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: University Hospital, Toulouse
First posted: 2022-02-02
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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)

Eligibility 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)

Primary outcomes:
measure: Influenza vaccination coverage
timeFrame: up to 5 months
Secondary outcomes:
measure: Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia
timeFrame: up to 5 months
measure: Factors associated with influenza non-vaccination
timeFrame: up to 5 months
measure: Reasons for influenza vaccination and non-vaccination
timeFrame: up to 5 months
measure: Covid-19 vaccination coverage including primo vaccination, booster
timeFrame: up to 5 months
measure: Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
Study officials:
affiliation: Hôpital Bicêtre
name: Raphaele Seror
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Adeline Ruyssen-Witrand
role: PRINCIPAL_INVESTIGATOR
References: