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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220423
• Other study ID #: ART- Influenza
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2022
• Source: Societe Francaise de Rhumatologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Influenza, Human
• Rheumatoid Arthritis

Intervention

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
• No reminders
no reminders on top of the National annual communication campaign organized by the French Health System authorities

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Le Kremlin-Bicêtre

Sponsors (3)

Lead Sponsor	Collaborator
Societe Francaise de Rhumatologie	Assistance Publique - Hôpitaux de Paris, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza vaccination coverage	The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups	up to 5 months
Secondary	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
Secondary	Factors associated with influenza non-vaccination	identification of the factors associated with the absence of vaccination assessed by questionnaire	up to 5 months
Secondary	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
Secondary	Covid-19 vaccination coverage including primo vaccination, booster	Estimation of the actual covid19 vaccination coverage rate	up to 5 months
Secondary	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

External Links

•   French National Registry - ART