User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients
- Conditions
- Asthma in ChildrenAsthma AttackAsthma AcuteAsthma Chronic
- Registration Number
- NCT03642418
- Lead Sponsor
- University of California, San Francisco
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Physician-diagnosed mild or moderate persistent asthma
- On controller therapy [inhaled corticosteroid (ICS), ICS + leukotriene receptor antagonist (LTRA), or ICS + long-acting beta agonist (LABA)] for at least the previous six months
- At least one severe exacerbation requiring systemic corticosteroids in the previous year
- Baseline FEV1 >/= 70% predicted for age, gender, and height according to published reference standards
- Parental consent and the child's assent
-
Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
-
Severe persistent asthma, as evidenced by any of the following:
- 3 hospitalizations
- 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms
-
Inability to perform acceptable spirometry
-
History of collapsed lung
-
History of syncope with forced exhalation
-
Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)
-
Lacking access to wireless local area networking (Wi-Fi™)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Yellow Zone episodes 44 weeks defined by the occurrence of any of the following: (1) Symptom Diary score \> 4 and (2) ATAQ score \> 1
- Secondary Outcome Measures
Name Time Method Red Zone episodes 44 weeks defined by the occurrence of any of the following:
ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization
Trial Locations
- Locations (1)
UCSF- Benioff Children Hospital
🇺🇸San Francisco, California, United States