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临床试验/NCT01669681
NCT01669681已完成不适用

Medical Economic Evaluation of the Care of the Severe Asthma : Cohort COBRA

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2011年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost

研究概览

简要总结

The severe asthma is a major source of expenses in term of public health, while it concerns no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations, care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort of more than 500 severe asthmatic patients multicentrique in an already widely established cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a real medical economic variable. The possibility of dynamic follow-up of the expenses compared to the medical data offers perspectives of evaluation cost-efficiency of the informed therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the data of health stemming from a cohort with the economic data stemming from the CPAM. This variable included in a Cluster's algorithm has to allow to identify the interventions the more and the less cost effective. The main objective of this study is to realize a cost estimate of care of the severe asthma. The variation of the costs will be also studied. The recruited patients are patients already included in the cohort COBRA in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.

详细描述

The following direct medical costs will be collected according to the point of view of the Social Security on a duration of 2 years:

  • Hospitalizations (valuation from the GHS + medicines except GHS)· Consultations (valuation AM)
  • Complementary(additional) examinations except hospitalization (valuation AM)
  • Pharmacy (valuation AM)
  • Transport (valuation AM)The estimate of average costs will be made with a reliable interval for 95 %.

The average cost by patient of the care will be calculated for every year of the follow-up. Relationship individual cost-efficiency: by analogy with the studies cost-efficiency comparative clauses, the investigators shall calculate a relationship cost-efficiency at the individual level as follows: (cost-year2 - cost-year1) / (efficiency-year2 - efficiency-year 1). Differences in these relationships will be looked for between various groups by tests of comparisons of averages.The construction of patients' clusters will be made according to the algorithm of the study SARP but also by using techniques statistics of classification non supervising to define our own algorithm. Variables used on our algorithm will include the relationship cost efficiency individual in addition to the clinical variables. The temporal stability of the relationship cost efficiency will be analyzed. The risk factors of a modification of this relationship will be looked for.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients included in the observationnal cohort COBRA for at least 6 months
  • Patient members in one of the partner health insurance funds

排除标准

  • The patient refusing his participation to the research

结局指标

主要结局

The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost

时间窗: Baseline

The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost (with a reliable interval in 95 %).

次要结局

  • The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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