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

NCT05220423 | Completed DMC

• 1 other identifier: ART- Influenza
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

anti-TNF; Flu; influenza; vaccination; biologics; bDMARDs; targeted therapies

Outcome Measures

Primary Outcomes (1)

• Influenza vaccination coverage

  The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups

  up to 5 months

Secondary Outcomes (5)

• Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia

  up to 5 months

• Factors associated with influenza non-vaccination

  up to 5 months

• Reasons for influenza vaccination and non-vaccination

  up to 5 months

• Covid-19 vaccination coverage including primo vaccination, booster

  up to 5 months

• Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment

  up to 5 months

Study Arms (2)

Reminders Group

OTHER

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

No reminders group

OTHER

This group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities

Other: No reminders

Interventions

sms and emails reminders OTHER

6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities

Reminders Group

No reminders OTHER

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

No reminders group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient already treated by the same anti-TNF in the past (same drug)

Sponsors & Collaborators

• Societe Francaise de Rhumatologie: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (1)

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Related Publications (1)

• Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.

  PMID: 39576675 DERIVED

Related Links

• French National Registry - ART

MeSH Terms

Conditions

Arthritis, Rheumatoid; Influenza, Human

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Raphaele Seror

  Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

• Adeline Ruyssen-Witrand

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient reported outcome
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 2, 2022
• Study Start: October 19, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)