Asthma Ctrl SMART Trial

ConditionsAsthma in Children Asthma Chronic

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-18

SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

Asthma Ctrl
Behavioral
Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
Asthma Ctrl+
Behavioral
Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
Control
Behavioral
Asthma management application providing education and automated reminders

Treatment groups

389 Participants

are divided into 3 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: Asthma CtrlExperimental treatment 1 intervention

Group C: Asthma Ctrl+Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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.

Other outcomes

Demographic Questionnaire

Adolescents and caregivers will complete a questionnaire to collect information about demographics.

Time frame

Baseline

Hardship questionnaire

Adolescents and caregivers will complete a 19-item validated questionnaire designed to capture current hardships.

Time frame

Baseline assessment and then at 6 months and 12 months

Asthma Knowledge

Adolescents will complete a 13-item a questionnaire assessing the extent to which they agree with facts or information about asthma to provide a measure of health beliefs.

Time frame

Baseline assessment and then at 6 months and 12 months

Adolescent Medication Barriers Scale (AMBS)

16 (adolescent) item report assessing perceived barriers to treatment adherence using a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on the AMBS are linked to poorer adherence and increased medical complications.

Time frame

Baseline assessment and then at 6 months and 12 months.

Sponsors and contacts

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Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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