Asthma Chronic, Asthma in Children
Conditions
Keywords
sequential, multiple assignment, randomized trial (SMART), adherence, asthma, adolescents
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAsthma Ctrl
Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
BEHAVIORALAsthma Ctrl+
Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
BEHAVIORALControl
Asthma management application providing education and automated reminders
Sponsors
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Sequential, multiple assignment, randomized trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patient age between 12-18 years * Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines * Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator * English fluency for patient, caregiver, and clinician
Exclusion criteria
* Significant cognitive deficits that may interfere with comprehension per medical team or chart review * Diagnosis of serious mental illness (e.g., schizophrenia) * Diagnosis of pervasive developmental disorder * Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia) * Patient receives school administered daily controller medication at the time of the enrollment visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electronically Monitored Controller Medication Adherence | 12 months | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Asthma Severity Index (CASI) | Baseline assessment and then once a month for 12 months | 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. |
| Asthma Control: Asthma Control Test (ACT) | Baseline assessment and then once a month for 12 months | 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 |
| Lung Function | Baseline and then once a month for 12 months | Mobile spirometry to capture Forced Vital Capacity (FVC) |
| Healthcare Utilization | Baseline assessment and then once a month for 12 months. | 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. |
| Asthma Exacerbations | Baseline assessment and then once a month for 12 months. | 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. |
Countries
United States
Contacts
CONTACTRachelle R Ramsey
PRINCIPAL_INVESTIGATORRachelle R Ramsey
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed