Tablet-assisted Training in Exacerbated COPD
2018年12月5日 更新者：Marie Carmen Valenza、Universidad de Granada
Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Granada
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Granada.、Granada、西班牙、18071
- Faculty of Health Sciences. University of Granada.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosed of exacerbation of COPD.
- To possess pharmacological treatment in the form of inhalers.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
接受医院提供的标准医疗和药理护理
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实验性的：Inhaler technique
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.
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The first day of the intervention consisted primarily of ventilatory re-education.
During the realization of the technique, he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction.
On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forced expiratory volume in the first second (FEV1)
大体时间：[Time Frame: baseline, 12 months]
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Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
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[Time Frame: baseline, 12 months]
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Knowledge of the Chronic Obstructive Pulmonary Disease
大体时间：[Time Frame: Baseline, 12 months]
|
Evaluated at baseline by Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010).
The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills.
A higher punctuation indicates better results.
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[Time Frame: Baseline, 12 months]
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Cognitive Level
大体时间：[Time Frame: Baseline]
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Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
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[Time Frame: Baseline]
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Functional independence
大体时间：[Time Frame: Baseline]
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Functional independence was assessed using the Functional Independence Mease Scale (FIM).
This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items.
The total score range between 18 points (total dependence) to 126 points (Independence completes).
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[Time Frame: Baseline]
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Anxiety-depression level
大体时间：[Time Frame: Baseline, 12 months]
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Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale.
Patients are going to complete this questionnaire composed of statements relevant to either generalized anxiety or depression.
It is composed of 14 items, 7 for anxiety and 7 for depression and higher values are related to higher depression and anxiety.
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[Time Frame: Baseline, 12 months]
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Adhesion to inhalers
大体时间：[Time Frame: Baseline]
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Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
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[Time Frame: Baseline]
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Dyspnea level
大体时间：[Time Frame: Baseline]
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Perceived perception of dyspnea was collected through the Modified Borg Scale.
Patients have to choose a number between 0 ( no dyspnea) to 10 (higher dyspnea).
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[Time Frame: Baseline]
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Physical fitness
大体时间：[Time Frame: baseline, 12 months]
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Physical fitness was assessed by performing the five-times-sit-to-stand test.
It consists of getting up and sitting five times in a row without a support.
The time period in which the exercise is performed is the patient's score with a maximum of 60 seconds
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[Time Frame: baseline, 12 months]
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Technique of the inhaler
大体时间：[Time Frame: baseline, 12 months]
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The evaluation of the technique of the inhalers was carried out by means of a checklist composed of 5 items.
Checked those points that were done correctly obtaining 5 points if the technique that was done correctly.
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[Time Frame: baseline, 12 months]
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Pressure expiratory force (PEF)
大体时间：[Time Frame: baseline, 12 months]
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Changes from baseline to postintervention in PEF were assessed using a peak flow.
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[Time Frame: baseline, 12 months]
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：M. Carmen Valenza, PH MD、Department of Physical Therapy. University of Granada.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月1日
初级完成 (实际的)
2018年6月23日
研究完成 (预期的)
2019年4月1日
研究注册日期
首次提交
2018年7月4日
首先提交符合 QC 标准的
2018年7月17日
首次发布 (实际的)
2018年7月26日
研究记录更新
最后更新发布 (实际的)
2018年12月6日
上次提交的符合 QC 标准的更新
2018年12月5日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.