Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Asthma
- Sponsor
- Arkansas Children's Hospital Research Institute
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- Change in Asthma Control Test (ACT) Score
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
Detailed Description
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH). We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥12 and \<21 years
- •Persistent asthma according to national guidelines criteria
- •Asthma Control Test (ACT) score ≤19
- •Prescribed a preventive (controller) asthma medication in the past 6 months
- •Access to a smartphone compatible with the PEAKmAAP and NutriMap
- •Access to the internet
- •Able to read and speak English
Exclusion Criteria
- •Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- •Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
- •Current smoker
- •Participation in the investigator's or other asthma clinical trials in the previous 6 months
Outcomes
Primary Outcomes
Change in Asthma Control Test (ACT) Score
Time Frame: 3 months
The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT \>19 (controlled asthma) at 3 months. ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma.
Secondary Outcomes
- Mediators of Asthma Control(12 months)
- Healthcare Utilization(12 months)
- Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes(12 months)
- Composite Asthma Severity Index (CASI) score(12 months)
- Asthma Control Classification(12 months)
- Lung Function and Airway Inflammation(12 months)