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临床试验/NCT03274180
NCT03274180Unknown不适用

A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.

研究概览

简要总结

A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover.

详细描述

The permanent Survey of French data"monitoring of tourist demand" shows that 20% of the French population over 15 years performed each year at least one trip abroad. Travel most frequently are destined for European countries (6 times out of 10). The fact remains, however, that the french travelers (roughly 4.5 million) then fall between 120 countries of which a quarter part of the health high risk area.

Most of these risks can be minimized if appropriate precautions are observed before, during, and after the travel.

The development of tourism of people living in France is a real public health issue.

In these conditions, the need for travel medicine becomes more pressing. Medical discipline in full expansion, it is initially preventive before the trip. The other role of the travel medicine is the diagnosis and the treatment of the pathology after the end of the travel, which involves strictly medical skills.

This research investigation is so limited to travel preventive consultation before departure.

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)

入排标准

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

入选标准

  • Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)

排除标准

  • Children and pregnant women,
  • Travellers (man and woman) with co-morbidity factors as:
  • Hospitalization in the month previous consultation
  • Travelers with at least an one disease including an immune deficiency or dys-immunity, such as auto-immune disease,
  • Any recent discovery comorbidity (since less than 6 months)
  • Any traveler coming for consultation and bearer of signs of an acute health problem.

研究组 & 干预措施

Nursing consultation

Experimental

travel preventive consultation was performed by nurse

干预措施: Nursing consultation (Other)

Medical consultation

No Intervention

travel preventive consultation was performed by a doctor

结局指标

主要结局

Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.

时间窗: At day 1

Evaluated by a post-consultation memorization survey

次要结局

  • The relevance of the choice of vaccinations proposed in relation to recommendations(At day 1)
  • Quality score of the support consultation evaluating the memorization of Information by travelers.(At day 1)
  • Level of satisfaction of travelers(At day 1)
  • The relevance of the choice of prescribed anti-malarials in relation to recommendation(At day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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