Clinical trial NCT05047419: Asthma in Pregnancy
Official title: Using Mobile Health Approaches to Improve Asthma Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Pregnancy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant and Not Pregnant participants with an Asthma diagnosis.

Brief summary: 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.

Detailed description: 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.

The purpose of this study is to determine if patients with asthma (pregnant and not pregnant) will take daily measurements with a peak flow meter and return them to the research team.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of Number of Peak Flow Measurements Received
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Linnea Polgreen, PHD
role: PRINCIPAL_INVESTIGATOR
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