NCT03642418

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held spirometer to determine the FEV1% predicted ranges that predict the Yellow Zone threshold.

Detailed description

The study hypothesizes that objective lung function tracking at-home, using a portable spirometer in addition to conventional symptom monitoring (in which asthmatic patients self-report and track their own symptoms), will result in more reliable detection of exacerbation in children 6-15 years old with asthma. This is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant ranges in FEV1% predicted that correlate with the Yellow Zone of the Asthma Action Plan. A total of 100 pediatric subjects (between the ages of 6 and 15 years old) with physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be enrolled from the ED, Inpatient Units, Pulmonary Medicine Clinic, and Allergy/Immunology Clinic at UCSF Benioff Children's Hospital San Francisco. Primary Specific Aim To determine the FEV1% predicted changes that correspond with a change from the Green to Yellow Zone. The primary outcome will be Yellow Zone episodes, as identified by the occurence of any of the following: Symptom Diary score \> 4 ATAQ score \> 1 Secondary Specific Aim To determine the FEV1% predicted changes that correspond with a change from the Yellow to Red Zone. The secondary outcome will Red Zone episodes, as identified by the occurence of any of the following: ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization

Conditions

• Asthma Acute
• Asthma in Children
• Asthma Chronic
• Asthma Attack

Timeline

• Start date: 2018-08-13
• Primary completion: 2019-12-31
• Completion: 2020-01-31
• First posted: 2018-08-22
• Last updated: 2020-07-15

Locations

1 site across 1 country: United States