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Completed

NCT Number: NCT05220423

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

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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Key information

About this study

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)

Who can participate

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

  • 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)

Treatment and study plan

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

No reminders

Other

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

Primary outcomes

  1. Influenza vaccination coverage

    Time frame: up to 5 months

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

Secondary outcomes

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

    Time frame: up to 5 months

    Comparison of the actual vaccination rate with the 2019-2020 vaccination rate

  2. Factors associated with influenza non-vaccination

    Time frame: up to 5 months

    identification of the factors associated with the absence of vaccination assessed by questionnaire

  3. Reasons for influenza vaccination and non-vaccination

    Time frame: up to 5 months

    Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire

  4. Covid-19 vaccination coverage including primo vaccination, booster

    Time frame: up to 5 months

    Estimation of the actual covid19 vaccination coverage rate

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

    Time frame: up to 5 months

    Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment

Sponsors and collaborators

Lead sponsor

Societe Francaise de Rhumatologie

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • University Hospital, Toulouse

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Oct 26, 2022

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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