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临床试验/NCT03601403
NCT03601403Unknown不适用

Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年12月1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
42
试验地点
1
主要终点
Forced expiratory volume in the first second (FEV1)

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of a tablet-assisted training in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

详细描述

The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed of exacerbation of COPD.
  • •To possess pharmacological treatment in the form of inhalers.

排除标准

  • •Inability to provide informed consent.
  • •Presence of psychiatric or cognitive disorders.
  • •Organ failure or cancer.
  • •Inability to cooperate.
  • •Patients who had experienced an exacerbation in the last month.

研究组 & 干预措施

CONTROL GROUP

No Intervention

Received the standard medical and pharmacological care provided by the hospital

Inhaler technique

Experimental

The intervention group received the standard medical and pharmacological care provided by the hospital. In addition, a tablet-assisted training on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program.

干预措施: inhaler technique (Device)

结局指标

主要结局

Forced expiratory volume in the first second (FEV1)

时间窗: [Time Frame: baseline, 12 months]

Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.

次要结局

  • Anxiety-depression level([Time Frame: Baseline, 12 months])
  • Cognitive Level([Time Frame: Baseline])
  • Dyspnea level([Time Frame: Baseline])
  • Physical fitness([Time Frame: baseline, 12 months])
  • Knowledge of the Chronic Obstructive Pulmonary Disease([Time Frame: Baseline, 12 months])
  • Technique of the inhaler([Time Frame: baseline, 12 months])
  • Pressure expiratory force (PEF)([Time Frame: baseline, 12 months])
  • Functional independence([Time Frame: Baseline])
  • Adhesion to inhalers([Time Frame: Baseline])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Principal investigator

Universidad de Granada

研究点 (1)

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