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临床试验/NCT03704545
NCT03704545已完成不适用

Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年1月18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
174
试验地点
2
主要终点
Number of exacerbation events

研究概览

简要总结

The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.

研究设计

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

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

  • The patient has signed the consent form.
  • The patient is affiliated to a health insurance programme
  • The patient is at least 18 years old (≥).
  • The patient is admitted to complete hospitalization (for patients in the "Hospital and Control" groups).
  • The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility.
  • The patient has one or more inhaler devices to treat Chronic Obstructive Pulmonary Disease.
  • The patient returns to his / her home when discharged from hospital (for patients in the "Hospital and Control" groups).
  • The patient is available for a follow-up of 12 months.

排除标准

  • The subject participates in another interventional study.
  • The subject is in an exclusion period determined by a previous study.
  • The patient is under safeguard of justice.
  • The subject refuses to sign the consent.
  • It is not possible to give the patient (or his/her trusted-person) informed information.

结局指标

主要结局

Number of exacerbation events

时间窗: Month 12

Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.

次要结局

  • Medication Possession Ratio(12 months)
  • Number of visits to the attending physician(Month 12)
  • device usage learning curve(12 months)
  • Number of hospitalisation events(Month 12)
  • Usability score of devices(Month 12)
  • satisfaction questionnaire(Month 12)
  • Number of visits to the pulmonologist(Month 12)
  • Number of visits to the hospital emergency service(Month 12)
  • Quality of life questionnaire(Month 12)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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