Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

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.

Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL). We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines.

We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning.

ACT a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indicating well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including ACT score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function. ACT scores may improve but remain ≤19 for participants with very poorly controlled asthma, we will assess for change in ACT score that is considered to be clinically important (as indicated by ≥3 point increase).The ACT score will be assessed via mobile survey to measure for sustained improvement throughout the study. We hypothesize that PCP data sharing will facilitate asthma control by alerting the PCP when asthma is worsening or failing to improve. The impact of PCP data sharing on ACT score will be measured to assess whether data sharing has added benefit to PEAKmAAP alone.

The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations.

Asthma guidelines categorize asthma control for individuals ≥12 years into 3 categories: well-controlled (WC), not well-controlled (NWC), or very poorly controlled (VPC). Asthma control is defined by the degree to which asthma manifestations are minimized by therapeutic intervention. Components of asthma control include measures of daytime symptoms, nighttime awakenings, activity limits, rescue medication use, and exacerbations requiring oral systemic corticosteroids. An assessment of asthma control will be made during the eligibility screening, at the in-person, structured interviews at baseline, 3 months and 12 months as well as via mobile survey at 6 and 9 months for all participants.

Spirometry is the test most used for the assessment of the risk for adverse events and impairment in asthma. Forced expiratory volume in the first second (FEV1) expressed as percent predictive of reference population value or as a proportion of the forced vital capacity (FEV1/FVC) will be assessed. FeNO is a quantitative, non-invasive measure of airway inflammation that predicts responsiveness and adherence to ICS. We will measure lung function and FeNO at baseline, 3 months, and 12 months for all participants.