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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: sms and emails reminders; Other: No reminders

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 Type: Interventional
• Enrollment (Actual): 446
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France
    • Hôpital Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reminders Group; This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities	Other: sms and emails reminders; 6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities
Other: No reminders group; This group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities	Other: No reminders; no reminders on top of the National annual communication campaign organized by the French Health System authorities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza vaccination coverage	The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups	up to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia	Comparison of the actual vaccination rate with the 2019-2020 vaccination rate	up to 5 months
Factors associated with influenza non-vaccination	identification of the factors associated with the absence of vaccination assessed by questionnaire	up to 5 months
Reasons for influenza vaccination and non-vaccination	Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire	up to 5 months
Covid-19 vaccination coverage including primo vaccination, booster	Estimation of the actual covid19 vaccination coverage rate	up to 5 months
Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment	Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment	up to 5 months

Collaborators and Investigators

• Sponsor: Societe Francaise de Rhumatologie
• Collaborators: Assistance Publique - Hôpitaux de Paris; University Hospital, Toulouse
• Investigators: Principal Investigator: Raphaele Seror, Hôpital Bicêtre; Principal Investigator: Adeline Ruyssen-Witrand, CHU Toulouse

Publications and helpful links

Helpful Links

• French National Registry - ART

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: influenza; vaccination; anti-TNF; Flu; biologics; targeted therapies; bDMARDs
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Orthomyxoviridae Infections; Arthritis; Arthritis, Rheumatoid; Influenza, Human
• Other Study ID Numbers: ART- Influenza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No