Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension (e-MOTION PH)
2017年12月19日 更新者：Bayer
(e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) over 6 months in routine clinical practice settings.
研究概览
详细说明
Remote patient monitoring can lead to improved patient outcomes, including improved quality of life, reduced readmissions, earlier treatment for symptoms detected prior to schedule in-office follow-up visits, improved communications with care providers, increased participation in self-management of disease, and an improved knowledge of their medical conditions .
In patients with PAH, daily activity level, as measured using a physical activity monitor for seven consecutive days, correlated with 6-minute walk distance (6MWD).
The monitor used in the aforementioned PAH study was positioned on the patients' right upper arm with an armband, as opposed to the more popular and more comfortable wristbands used today, such as the Fitbit Flex.
Although the aforementioned PAH study did show a correlation between activity level monitoring and 6MWD, the patients were monitored for only seven days.
It is still unknown whether this correlation would exist over a longer trial period and whether patients, their caregivers, and clinicians would find activity level monitoring useful in helping manage PH.
研究类型
观察性的
注册 (实际的)
35
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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Multiple Locations、加拿大
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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 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
取样方法
非概率样本
研究人群
Canadian patients are eligible for the study if they have been diagnosed with symptomatic Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and are stable on optimal medical therapy and who meet the study's eligibility criteria
描述
Inclusion Criteria:
- Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),
- Age ≥ 18 years,
- Baseline 6 Minute Walk Distance (6MWD) a minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial)
- WHO Functional Class II or III,
Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no:
- decline in World Health Organization (WHO) Function class or,
- decline in 6MWD by 15% or,
- change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or,
- Introduction of parenteral Prostacyclin Analog (PCA) treatment.
- Patients provide written informed consent, are able to understand and follow instructions.
Exclusion Criteria:
- Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band),
- Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,
- Enrolled in pulmonary rehabilitation program within last 6 months,
- Participating in an interventional 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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patients with PAH and CTEPH
Patients diagnosed with symptomatic Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and stable on optimal medical therapy who meet the study's eligibility criteria
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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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6-minute walk distance (6MWD)
大体时间：At baseline
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(performed by investigator)
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At baseline
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6-minute walk distance (6MWD)
大体时间：At 3 months
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(performed by investigator)
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At 3 months
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6-minute walk distance (6MWD)
大体时间：At 6 months
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(performed by investigator)
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At 6 months
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Number of steps per day
大体时间：At baseline
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(monitored by Fitbit Flex)
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At baseline
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Number of steps per day
大体时间：At 3 months
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(monitored by Fitbit Flex)
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At 3 months
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Number of steps per day
大体时间：At 6 months
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(monitored by Fitbit Flex)
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At 6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)
大体时间：At baseline, 3 months and 6 months
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At baseline, 3 months and 6 months
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Change in compliance with medication using the Moriky´s Questionnaire
大体时间：At baseline, 3 months and 6 months
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At baseline, 3 months and 6 months
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Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
大体时间：At baseline, 3 months and 6 months
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At baseline, 3 months and 6 months
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Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD
大体时间：At baseline, 3 months and 6 months
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At baseline, 3 months and 6 months
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Healthcare provider Satisfaction and Usability questionnaire
大体时间：At 3 months and 6 months
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At 3 months and 6 months
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Caregiver Satisfaction and Usability questionnaire
大体时间：At 3 months and 6 months
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At 3 months and 6 months
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Patient Satisfaction and Usability questionnaire
大体时间：At 3 months and 6 months
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At 3 months and 6 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。
赞助
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)
2015年6月30日
初级完成 (实际的)
2016年11月25日
研究完成 (实际的)
2016年12月21日
研究注册日期
首次提交
2015年8月10日
首先提交符合 QC 标准的
2015年8月31日
首次发布 (估计)
2015年9月1日
研究记录更新
最后更新发布 (实际的)
2017年12月20日
上次提交的符合 QC 标准的更新
2017年12月19日
最后验证
2017年12月1日
更多信息
与本研究相关的术语
其他研究编号
- 17926
- DBOX 2014/00466 (其他标识符：Company internal)
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.