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临床试验/NCT02162576
NCT02162576已完成不适用

Asthma Data Innovation Demonstration Project: Impact of a Mobile Health, Sensor-driven Asthma Management Platform on Asthma Symptoms, Control and Self-management

David Van Sickle2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Change in Rescue Inhaler Actuations/Person/Day

研究概览

简要总结

Propeller Health is collaborating with the City of Louisville and other local partners to carry out a focused demonstration project that will evaluate the effectiveness of the Propeller Health approach to asthma management while exploring means to use real-time data on asthma exacerbations in a public health setting. The Asthma Data Innovation Demonstration Project (ADID) will use wireless sensor technology to develop spatial and temporal data on the use of rescue inhalers by 120 study subjects with asthma in the Louisville metropolitan area. Propeller Health will process these data to support two general strategies.

Asthma self management: Rescue inhaler actuation data will be compiled into individualized feedback reports to support asthma self management. Propeller Health will combine information on individual rescue inhaler actuations with evidence-based asthma management tips into real-time reports that will be provided to subjects. ADID staff will evaluate any resulting improvements in asthma control that may be based on this information. Subjects may share reports with their healthcare providers.

Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial and temporal asthma rescue inhaler actuation data to City personnel and authorized public health researchers in Louisville. These data will show the times and locations of the use of rescue inhalers by the 120 study subjects throughout the greater Louisville area. ADID staff will work with City personnel and researchers to investigate how this unprecedented level of detailed information on exacerbations can be used best to increase public awareness of environmental triggers while supporting public health surveillance efforts around respiratory diseases.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported provider diagnosis of asthma
  • Prescription for Short Acting Beta Agonist (SABA) at study intake

排除标准

  • Subject is under the age of 5 at the beginning of the study
  • Subject does not speak English
  • Subject does not have access to the Internet or email to receive reports
  • Subject has substantial co-morbidity (self-reported provider diagnosis of COPD)

结局指标

主要结局

Change in Rescue Inhaler Actuations/Person/Day

时间窗: Change from baseline to study exit, up to 13 months

The Propeller Health sensor permits the capture of objective time and location data on each actuation of the rescue inhaler. The mean number of rescue inhaler events per participant per day will be assessed for each day in the study, and the difference between the baseline month and all subsequent months will be evaluated.

次要结局

  • Percent Change in the Proportion of Participants With an Asthma-free Day(Change from baseline period to study exit (approximately 13 months))
  • Percent Change in the Proportion of Participants With Well-controlled Asthma(Baseline and study exit (approximately 13 months))

研究者

申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

David Van Sickle

CEO

Reciprocal Labs

研究点 (2)

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