Hôpital Bicêtre
Le Kremlin-Bicêtre, France
NCT Number: NCT05220423
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Le Kremlin-Bicêtre, France
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
All patients included in the French ART Registry (rheumatoid arthritis and anti-TNF) and participating to the e-cohort.
Inclusion criteria
Exclusion criteria
6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities
no reminders on top of the National annual communication campaign organized by the French Health System authorities
Time frame: up to 5 months
The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups
Time frame: up to 5 months
Comparison of the actual vaccination rate with the 2019-2020 vaccination rate
Time frame: up to 5 months
identification of the factors associated with the absence of vaccination assessed by questionnaire
Time frame: up to 5 months
Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire
Time frame: up to 5 months
Estimation of the actual covid19 vaccination coverage rate
Time frame: up to 5 months
Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment
Societe Francaise de Rhumatologie
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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