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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sms and emails reminders
No reminders
Sponsored by
Societe Francaise de Rhumatologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring anti-TNF, Flu, influenza, vaccination, biologics, bDMARDs, targeted therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Bicêtre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Reminders Group

No reminders group

Arm Description

This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia
Comparison of the actual vaccination rate with the 2019-2020 vaccination rate
Factors associated with influenza non-vaccination
identification of the factors associated with the absence of vaccination assessed by questionnaire
Reasons for influenza vaccination and non-vaccination
Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire
Covid-19 vaccination coverage including primo vaccination, booster
Estimation of the actual covid19 vaccination coverage rate
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

Full Information

First Posted
December 23, 2021
Last Updated
October 25, 2022
Sponsor
Societe Francaise de Rhumatologie
Collaborators
Assistance Publique - Hôpitaux de Paris, University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05220423
Brief Title
Effectiveness of SMS Reminders on Influenza Vaccination Coverage in Patients With RA in the ART Registry
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Societe Francaise de Rhumatologie
Collaborators
Assistance Publique - Hôpitaux de Paris, University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
anti-TNF, Flu, influenza, vaccination, biologics, bDMARDs, targeted therapies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
patient reported outcome
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reminders Group
Arm Type
Other
Arm Description
This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities
Arm Title
No reminders group
Arm Type
Other
Arm Description
This group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities
Intervention Type
Other
Intervention Name(s)
sms and emails reminders
Intervention Description
6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities
Intervention Type
Other
Intervention Name(s)
No reminders
Intervention Description
no reminders on top of the National annual communication campaign organized by the French Health System authorities
Primary Outcome Measure Information:
Title
Influenza vaccination coverage
Description
The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups
Time Frame
up to 5 months
Secondary Outcome Measure Information:
Title
Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia
Description
Comparison of the actual vaccination rate with the 2019-2020 vaccination rate
Time Frame
up to 5 months
Title
Factors associated with influenza non-vaccination
Description
identification of the factors associated with the absence of vaccination assessed by questionnaire
Time Frame
up to 5 months
Title
Reasons for influenza vaccination and non-vaccination
Description
Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire
Time Frame
up to 5 months
Title
Covid-19 vaccination coverage including primo vaccination, booster
Description
Estimation of the actual covid19 vaccination coverage rate
Time Frame
up to 5 months
Title
Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment
Description
Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment
Time Frame
up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaele Seror
Organizational Affiliation
Hôpital Bicêtre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adeline Ruyssen-Witrand
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bicêtre
City
Le Kremlin-Bicêtre
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03062865
Description
French National Registry - ART

Learn more about this trial

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

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