跳至主要内容
临床试验/NCT05047419
NCT05047419已完成不适用

Using Mobile Health Approaches to Improve Asthma Treatment

Linnea Polgreen1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
Comparison of Number of Peak Flow Measurements Received

研究概览

简要总结

The long-term goal is to improve the care of patients with asthma. The overarching objective of this pilot grant is to test the feasibility, acceptability and potential clinical utility of deploying a mobile-health intervention to improve asthma surveillance.

详细描述

Asthma is a major cause of morbidity. Asthma is frequently underdiagnosed, and proven therapies are underused. Even among patients treated for asthma, adherence to treatment is often is suboptimal.

Adherence to asthma therapy depends not only on regular use of therapies, but also correct technique for inhaler use. To improve treatments, home-based interventions have been proposed. Many such solutions involve collecting patient data to motivate patients and alert providers to ongoing problems. Examples of proposed solutions include using an app to keep symptom and medication logs, using Fitbits to document physical limitations, and nighttime breathing sensors. Other proposals include using peak expiratory flow meters, portable spirometers, and portable oscillometry. While promising, most of these efforts have, to date, not expanded widely beyond research settings.

Asthma during pregnancy is especially important to treat. Uncontrolled asthma is associated with preeclampsia, low birth weight, and fetal death. For some patients asthma is less severe during pregnancy, but for others, asthma worsens. In addition, pregnant patients with asthma often decrease use of medication or stop therapy altogether. Many pregnant patients stop therapy due to worry about negative effects on the baby. In general, asthma therapy is safe for pregnant patients and the babies, and hypoxia is dangerous for both.

Despite the importance of asthma treatment during pregnancy, some healthcare providers do not encourage pregnant patients with asthma to continue with asthma treatment. Many providers do not feel qualified to educate and treat patients during pregnancy, and pregnant patients may not be adequately informed that asthma therapy is safe. Also, pregnant patients may minimize their symptoms if worried about the safety of therapies. Accordingly, collecting objective information from patients in the home environment could improve the health of pregnant patients and the babies. Home monitoring may be especially important for patients living in rural areas with limited access to healthcare.

Home measurements of asthma symptoms can supplement clinic visits. However, this approach requires disciplined follow-up on the part of both patients and the healthcare team. Patients are required to use peak flow meters and regularly share results with providers. In addition, healthcare providers need to act on the shared data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Able to read and write in English or Spanish;
  • Current patient at participating clinic;
  • Diagnosis of asthma;
  • Owns a smartphone capable of supporting Bluetooth-enabled peak flow meter.

排除标准

  • 3rd trimester of pregnancy;
  • Current prisoner status;
  • Unable to provide own written informed consent.

研究组 & 干预措施

Pregnant Participants with Asthma

Participants will be asked to use peak flow meter each day from enrollment to 6 weeks post due date and send peak flow and FEV1 values to the research team via text message. Also, every 3 months participants will be asked to send in a PDF of the values from the peak flow meter app for the previous 7 days via email as a validation of the text message values.

Not Pregnant Participants with Asthma

Participants will be asked to use peak flow meter each day from enrollment to 9 months and send peak flow and FEV1 values to the research team via text message. Also, every 3 months participants will be asked to send in a PDF of the values from the peak flow meter app for the previous 7 days via email as a validation of the text message values.

结局指标

主要结局

Comparison of Number of Peak Flow Measurements Received

时间窗: 9 months

Comparison of number of peak flow measurements received between pregnant and not pregnant groups.

次要结局

未报告次要终点

研究者

发起方
Linnea Polgreen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Linnea Polgreen

Associate Professor

University of Iowa

研究点 (1)

Loading locations...

相似试验