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Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool. (PREMIERE)

2020年12月8日 更新者：Novartis Pharmaceuticals

A 52-week Multi-center Randomized Trial to Evaluate Remote Patient Monitoring Using the EXACT Patient-reported Outcome Tool on Reduction of Hospitalizations From Exacerbations in Patients With Chronic Obstructive Pulmonary Disease as Compared to Those Managed by Usual Care

The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD population at high risk of exacerbation, compared to those managed by usual care.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study uses two parallel groups of approximately 100 patients in each arm. After a screening period to confirm eligibility, patients will be randomized to either the RPM system group, or the usual care group. Both groups will be followed for 52 weeks until the end of study. There are only 4 planned study visits and patients will continue on their usual treatment.

The remote patient monitoring system will issue an alert to the clinical site once the established threshold change has been reached. The alert notification will require the clinical site to contact the patient and treat the patient based on clinical judgment and clinical practice. Patients in the usual care arm will be managed through their normally nurse/physician contact.

研究类型

介入性

注册 (实际的)

118

阶段

  • 阶段1

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

  • 瑞典
      • Gagnef、瑞典、785 21
        • Novartis Investigative Site
      • Göteborg、瑞典
        • Novartis Investigative Site
      • Kungshamn、瑞典、456 31
        • Novartis Investigative Site
      • Lund、瑞典、SE-221 85
        • Novartis Investigative Site
      • Lund、瑞典、222 22
        • Novartis Investigative Site
      • Stockholm、瑞典、113 61
        • Novartis Investigative Site
      • Östersund、瑞典、831 83
        • Novartis Investigative Site
  • 西班牙
      • Madrid、西班牙、28034
        • Novartis Investigative Site
      • Madrid、西班牙、28040
        • Novartis Investigative Site
      • Torremolinos、西班牙、29620
        • Novartis Investigative Site
    • Catalunya
      • Barcelona、Catalunya、西班牙、08036
        • Novartis Investigative Site
    • Cataluña
      • Barcelona、Cataluña、西班牙、08025
        • Novartis Investigative Site
      • Barcelona、Cataluña、西班牙、08035
        • Novartis Investigative Site
      • Girona、Cataluña、西班牙、17007
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat、Cataluña、西班牙、08907
        • Novartis Investigative Site
      • Lerida、Cataluña、西班牙、25198
        • Novartis Investigative Site
      • Sant Boi de Llobregat、Cataluña、西班牙、08830
        • Novartis Investigative Site
      • Sant Cugat、Cataluña、西班牙、08190
        • Novartis Investigative Site
      • Sant Joan Despí、Cataluña、西班牙、08970
        • Novartis Investigative Site
    • Madrid
      • Majadanonda、Madrid、西班牙、28220
        • Novartis Investigative Site

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:

  • Outpatients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), GOLD grade 2 or higher as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, Updated 2011, including:
  • Current or ex-smokers with a smoking history of at least 10 pack years nt
  • Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the predicted normal value within 12 months prior to screening or at screening
  • Post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 70% within 12 months prior to screening or at screening
  • A documented history of at least 2 COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics in the previous 12 months prior to the screening visit, at least one of which required hospitalization.

Exclusion criteria:

  • Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Patients who have a COPD exacerbation not clinically resolved within 30 days prior to screening.
  • Patients with a history of asthma, indicated by (but not limited to) the onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Remote patient monitoring
Remote patient monitoring system including the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) tool can use changes in daily scores over a certain threshold level to alert notification to the clinical site. The site will contact the patient in order to determine the clinical significance associated with the change in score, and to treat the patient based on clinical judgment and clinical practice.
设备：Remote Patient Monitoring
Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter
实验性的：Usual care
This group of patient will continue on their usual standard care as close to real life situation as possible.
其他：Usual care
Patients in the usual care arm will continue their normally established procedures of nurse/physician contact and evaluation, as is considered standard for each individual practitioner in the study.

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
The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
大体时间：52 weeks
Comparison of the total number of hospitalizations and emergency room visits (combined) for management of Chronic Obstructive Pulmonary Disease (COPD) exacerbation(s) between the two arms
52 weeks

次要结果测量

结果测量
措施说明
大体时间
Lenght of hospitalization
大体时间：52 weeks
Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.
52 weeks
Time to first hospitalization
大体时间：52 weeks
Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.
52 weeks
Use of health care resources
大体时间：52 weeks
Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.
52 weeks
Number of medical visits
大体时间：52 weeks
Comparison of the number of medical visits combined (hospitalizations, emergency room visits, unscheduled and scheduled office visits) for management of COPD between the two arms.
52 weeks

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。

赞助

Novartis Pharmaceuticals

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。

有用的网址

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

2012年6月1日

初级完成 (实际的)

2014年1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

2012年12月4日

首先提交符合 QC 标准的

2012年12月5日

首次发布 (估计)

2012年12月6日

研究记录更新

最后更新发布 (实际的)

2020年12月10日

上次提交的符合 QC 标准的更新

2020年12月8日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CIDD001D2401

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.

Remote Patient Monitoring的临床试验

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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