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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: No reminders; Other: sms and emails reminders

• Registration Number: NCT05220423
• Lead Sponsor: Societe Francaise de Rhumatologie

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)

Study Timeline

• Study Start: 2021-10-19
• Study First Submitted: 2021-12-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No reminders group	No reminders	This group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities
Reminders Group	sms and emails reminders	This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities

Primary Outcome Measures

Name	Time	Method
Influenza vaccination coverage	up to 5 months	The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups

Secondary Outcome Measures

Name	Time	Method
Factors associated with influenza non-vaccination	up to 5 months	identification of the factors associated with the absence of vaccination assessed by questionnaire
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
Covid-19 vaccination coverage including primo vaccination, booster	up to 5 months	Estimation of the actual covid19 vaccination coverage rate
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
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

Trial Locations

Locations (1)

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France