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临床试验/NCT03587610
NCT03587610已完成不适用

Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe

Centre Hospitalier le Mans1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2018年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
1
主要终点
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older

研究概览

简要总结

In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 65 years or older
  • Patients capable of understanding and giving informed consent to participate in the study
  • Valid social security coverage

排除标准

  • Patients under judicial safeguard measures
  • Refusal to participate in the study
  • Vaccination contra-indication
  • Patient already included in the study

研究组 & 干预措施

Intervention arm

Active Comparator
  • if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date
  • if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination.

干预措施: Remedial vaccination (Biological)

Standard care

No Intervention
  • if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date
  • if the patients vaccinations are not up to date: the patient will be informed that a remedial vaccination is necessary and that he should contact his primary care provider after hospital discharge.

结局指标

主要结局

Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older

时间窗: two months

Difference in the increase in vaccination coverage between the two arms, measured as a percentage

次要结局

  • Immunisation rate according to sex among patients 65 years or older(two months)
  • Immunisation rate according to primary care coverage among patients 65 years of age or older(two months)
  • Immunisation rate according to socio professional category(two months)
  • Immunisation rate among patients 65 years of age or older in the Sarthe department of France(two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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