Monitoring Adherence Using Mobile Technology
2016年9月14日 更新者：University of Colorado, Denver
This study plans to learn more about how children use their asthma medicines.
The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma
研究概览
研究类型
观察性的
注册 (实际的)
25
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
6年 至 17年 (孩子)
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
Study subjects would be drawn from the list of high risk asthma patients and by pre-clinic chart review done by study investigator.
描述
Inclusion Criteria:
- age 6-17 years and their parents
- either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months
- requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (LABA).
- Patients using metered dose inhaler therapy would be eligible. Patients may also be on leukotriene antagonists,
- Must be made aware that they will have to read and accept to the terms of the User Agreement prior to enrollment in the study. If they do not agree they will not be able to continue participation. The User agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request.
Exclusion Criteria:
- Primary language other than English or Spanish
- Presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status.
- Patients using diskus therapy.
- Patients only on leukotriene antagonists.
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
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Intervention
All patients will be enrolled in one arm.
These patients will have monitoring devices placed on their asthma controller and rescue medication, with data transmitted both to their smartphones and a dashboard accessed by their primary pediatric pulmonary provider.
|
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 |
|---|---|---|
|
Number of patient participants that rate the devices as easy to use
大体时间：3 months
|
Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having children/parents answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.
|
3 months
|
|
Number of provider participants that rate the devices as easy to use
大体时间：3 months
|
Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having providers answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of patients/parents that exhibit behavioral changes with respect to taking asthma medications as a result of information gained from the monitoring devices.
大体时间：3 months
|
How many parents/patients of high risk asthmatic children change behavior regarding how they administer their medications as a result of information that they gained from the devices regarding their adherence to their treatment regimen, gained via phone surveys at 1.5 and 3 months after using the devices.
Patients are surveyed if children are greater than 12 years old.
Parents are surveyed if children are 6-12 years old.
|
3 months
|
|
Number of pediatric pulmonary providers that exhibit behavioral changes with respect to prescribing asthma medications as a result of information gained from the monitoring devices.
大体时间：3 months
|
Number of healthcare providers (physicians, nurse practitioners and physician assistants) that feel that their decision-making is affected regarding medication regimens for asthma based on information that they receive on patient adherence from the devices based on survey data gathered at study entry and 3 months after initiation of the devices will be measured.
|
3 months
|
|
Correlation of lung function to percent use of controller medications as measured by adherence devices.
大体时间：3 months
|
Evaluate correlation of markers of lung function (spirometry, fractional exhaled nitric oxide (FeNO), with percent adherence as measured by the monitoring devices.
|
3 months
|
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：Stanley Szefler, MD、University of Colorado, Denver
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
2015年12月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2015年11月24日
首先提交符合 QC 标准的
2015年11月25日
首次发布 (估计)
2015年12月1日
研究记录更新
最后更新发布 (估计)
2016年9月16日
上次提交的符合 QC 标准的更新
2016年9月14日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 15-0211
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.