Asthma in Pregnancy
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|ClinicalTrials.gov Identifier: NCT05047419|
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : October 5, 2021
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Using Mobile Health Approaches to Improve Asthma Treatment|
|Actual Study Start Date :||August 27, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
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.
- Comparison of Number of Peak Flow Measurements Received [ Time Frame: 9 months ]Comparison of number of peak flow measurements received between pregnant and not pregnant groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047419
|Contact: Linnea Polgreen, PHDfirstname.lastname@example.org|
|Contact: Shelby Francis, PHDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals & Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Shelby L Francis, PhD 319-775-0689 firstname.lastname@example.org|
|Principal Investigator:||Linnea Polgreen, PHD||University of Iowa|