Rheumatoid Arthritis
Conditions
Keywords
anti-TNF, Flu, influenza, vaccination, biologics, bDMARDs, targeted therapies
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)
Interventions
OTHERsms and emails reminders
6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities
OTHERNo reminders
no reminders on top of the National annual communication campaign organized by the French Health System authorities
Sponsors
Assistance Publique - Hôpitaux de Paris
University Hospital, Toulouse
Societe Francaise de Rhumatologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
patient reported outcome
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza vaccination coverage | up to 5 months | The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia | up to 5 months | Comparison of the actual vaccination rate with the 2019-2020 vaccination rate |
| Factors associated with influenza non-vaccination | up to 5 months | identification of the factors associated with the absence of vaccination assessed by questionnaire |
| Reasons for influenza vaccination and non-vaccination | up to 5 months | Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire |
| Covid-19 vaccination coverage including primo vaccination, booster | up to 5 months | Estimation of the actual covid19 vaccination coverage rate |
| Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment | up to 5 months | Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment |
Countries
France
Outcome results
None listed