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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Influenza vaccination coverage
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
patient reported outcome
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient already treated by the same anti-TNF in the past (same drug)
结局指标
主要结局
Influenza vaccination coverage
时间窗: up to 5 months
The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups
次要结局
- Factors associated with influenza non-vaccination(up to 5 months)
- Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia(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)