Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation (RHCluster4GR)
2015年2月21日 更新者：Konstantinos Gourgoulianis、Regional Health Authority of Sterea & Thessaly
Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation
The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life.
In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.
研究概览
详细说明
The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care.
Following this; it is also hypothesized that this will also lead to less patients' deaths.
In addition the patients' satisfaction using the telemedicine service will be studied.
A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
研究类型
介入性
注册 (实际的)
155
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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Thessaly
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Larisa、Thessaly、希腊、41110
- Pulmonary Department - Regional University Hospital of Larisa
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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
40年 及以上 (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:
- Exacerbation of COPD according to the GOLD guidelines
- Age > 40 years
- Capability to use the devices provided
- Willing to participate
Exclusion Criteria:
included in previous COPD monitoring study
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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实验性的：远程监控
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Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment.
Patients are followed by a dedicated telehealth centre.
Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications.
Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks.
When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre.
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无干预：Usual care
Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed.
In the case of clinical deterioration during the study, the patients contact as usual their general practitioner.
Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed
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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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Number of hospital readmissions
大体时间：3 months period
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Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation
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3 months period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
大体时间：3 months - at the entry point of the intervention and the end.
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Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
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3 months - at the entry point of the intervention and the end.
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Hospital anxiety and depression scale HADS
大体时间：3 months - at the entry point of the intervention and the end.
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Hospital anxiety and depression scale HADS
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3 months - at the entry point of the intervention and the end.
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Health status, measured with the St. George's Respiratory Questionnaire SGRQ
大体时间：3 months - at the entry point of the intervention and the end.
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Health status, measured with the St. George's Respiratory Questionnaire SGRQ
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3 months - at the entry point of the intervention and the end.
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Lung condition as measured by FEV1
大体时间：1 month after the hospital discharge.
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Lung condition as measured by FEV1
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1 month after the hospital discharge.
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Mortality
大体时间：3 months period
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Mortality
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3 months period
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Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
大体时间：at the 3rd month of the tele-monitoring
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Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)
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at the 3rd month of the tele-monitoring
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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。
合作者
调查人员
- 首席研究员：Konstantinos Gourgoulianis, MD, PhD、Pulmonary Department - University Hospital of Larisa
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年3月1日
初级完成 (实际的)
2013年11月1日
研究完成 (实际的)
2014年1月1日
研究注册日期
首次提交
2011年12月6日
首先提交符合 QC 标准的
2011年12月7日
首次发布 (估计)
2011年12月9日
研究记录更新
最后更新发布 (估计)
2015年2月24日
上次提交的符合 QC 标准的更新
2015年2月21日
最后验证
2015年2月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FR2017
- EC Grant Agreement 250487 (其他赠款/资助编号：European Commission CIP/PSP-ICT Grant Agreement 250487)
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.