The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
Our goal is to evaluate our promising mHealth intervention (Asthma Ctrl) that is easily accessible and tailored based on adherence barriers and to examine predictors of treatment response. In this multi-site R01 with Children's Hospital Colorado, the study investigators will conduct a 2-stage sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma. Following a baseline period, adolescents will be randomized to a mHealth asthma management app (control group) or Asthma Ctrl, a text-messaging intervention providing adherence feedback based on adherence monitoring (treatment) for SMART Stage 1. Participants will be excluded from the study if they have an adherence that is \>68%. For SMART Stage 2, adolescents randomized to the treatment group who demonstrate non-adherence (≤68% adherence; non-response) will undergo a second randomization to receive either 1) continued Asthma Ctrl (text messaging) or 2) Asthma Ctrl+ (Asthma Ctrl augmented with a problem-solving intervention delivered via telehealth). Thus, there are three intervention strategies that will be tested in this SMART: #1 control condition, #2 treatment, and #3 adapted treatment after Stage 2 and at follow-up (1 and 6 months). This innovative SMART design will address objectives described in the brief summary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
389
Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
Asthma management application providing education and automated reminders
University of Colorado AMC
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Electronically Monitored Controller Medication Adherence
Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%.
Time frame: 12 months
Composite Asthma Severity Index (CASI)
A weighted score comprised of: 1. number of days with symptoms and albuterol use in past 2 weeks 2. number of nights with symptoms and albuterol use in past 2 weeks 3. Type/dose of controller medication 4. Exacerbations (i.e., prednisone burst, hospitalizations) in last 2 months The CASI score, ranging from 0 to 20 points, includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The CASI is designed for children and adults ages 6 and older. A CASI score in the range of 0 to 3 indicates low severity. A CASI score greater than 3 may indicate medium to high asthma severity.
Time frame: Baseline assessment and then once a month for 12 months
Asthma Control: Asthma Control Test (ACT)
Five-item adolescent self-report, 4-week recall of frequency of asthma symptoms, use of rescue medications, effect of asthma on daily functioning, perception of asthma control. Items are rated using a 5-point scale. The total score ranges from 5 to 25. A score of 19 or less indicates that asthma may not be well controlled, signaling the need for a review with a healthcare provide
Time frame: Baseline assessment and then once a month for 12 months
Lung Function
Mobile spirometry to capture Forced Vital Capacity (FVC)
Time frame: Baseline and then once a month for 12 months
Lung Function
Mobile Spirometry to capture Forced Expiratory Volume in 1 second (FEV1)
Time frame: Baseline and then once a month for 12 months.
Lung Function
Mobile spirometry to capture Ration of Forced Expiratory Volume to Forced Vital Capacity (FEV1/FVC)
Time frame: Baseline and then once a month for 12 months
Lung Function
Mobile Spirometry to capture Forced Expiratory Flow (FEF)
Time frame: Baseline and then once a month for 12 months
Healthcare Utilization
Patients and caregivers will self-report the occurrence of asthma-related emergency department and urgent care visits, hospital admissions, and ICU admissions in the past month. Study staff will also review the patient's medical chart for the above information as well as asthma-intubation.
Time frame: Baseline assessment and then once a month for 12 months.
Asthma Exacerbations
Adolescents will provide a two-week recall of their use of oral steroids to treat an exacerbation. Study staff will also review the medical chart for this information.
Time frame: Baseline assessment and then once a month for 12 months.
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