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临床试验/NCT03474575
NCT03474575已完成不适用

EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Rate of hospitalizations

研究概览

简要总结

The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.

Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.

Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.

详细描述

Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS) , Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.

This program implements ambulatory care immediately after leaving the emergency department with a main goal of reducing hospital readmission during the first month. The home-based support includes daily visits at home conducted by the home care provider's nurses from day 1 to day 7, telephone calls at days 14 and 21 and a final home visit one month after discharge from the emergency department. Blood samples will be collected at inclusion, day 7 and one month during home visit and urine samples at inclusion, day 2, day 4 and one month during home visit .Telephone follow-up at 3, 6 months and one year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age ≥ 40 years
  • Current or former smoker, with at least 10 pack-years
  • previous history of COPD with concordant spirometry results
  • Admission to the emergency department for an exacerbation defined as an acute event which is characterized by a degradation of respiratory symptoms greater than the usual daily variations and requiring a change in therapeutic management
  • Patient with mild exacerbation characterized by a DECAF score at 0 or
  • (DECAF score: Dyspnea, Eosinopenia, Consolidation on chest x-ray, Acidaemia, and atrial Fibrillation. One point for each criterion. Mortality at one month is less than 3% if the DECAF score is 0 or 1).
  • Residence within 30km of Grenoble Alps University Hospital
  • Patient legally able to give consent
  • Person affiliated to a medical insurance

排除标准

  • Dementia or non-communicating patient in French language
  • Patient unable to call the emergency department at any time in case of sudden worsening
  • Pregnancy or breastfeeding woman
  • patient under administrative or judicial supervision
  • DECAF Score >
  • Patient's with DECAF score > 1 are considered at too high risk of mortality to be managed at home (they are usually hospitalized).

结局指标

主要结局

Rate of hospitalizations

时间窗: 90 days

number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay

次要结局

  • hospitalization rate for COPD exacerbation aggravation(3,6 and 12 months)
  • Hospitalization rate for worsening for cardio-respiratory symptoms(one year)
  • Mortality(3, 6 and 12 months)
  • Rate of all cause of hospitalizations(6 months and one year)
  • Determinants of hospitalization(30 days)
  • Differential of biological and clinical markers(30 days)
  • Differential of medical average cost per patient(3 months)
  • Acceptance rate of early ambulatory care(1 year)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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