Improving Medication Adherence using an Adaptive mHealth Intervention in Adolescents with Asthma

Cincinnati Childrens Hosp Med Ctr, Cincinnati OH

Investigators

Abstract

Asthma affects over 10 million youth in the United States and is associated with substantial morbidity, emotional impact, and an annual $56 billion in costs of care. One major contributor to the significant public health burden of asthma is nonadherence to prescribed medical treatment, with rates of non-adherence up to 70% in adolescents with asthma. Our work has demonstrated that although behavioral interventions improve adherence generally, interventions are not effective for all children with asthma. Our iteratively developed stepped care mHealth intervention (Asthma Ctrl) was designed to improve adherence by using an adaptable intervention conserving patient, family, and provider time, costs, and resources. Results from our pilot RCT demonstrated feasibility, acceptability and clinically significant improvements in adherence and asthma outcomes. The aim of this proposed multi-site R01 is to conduct a two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our stepped-care mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma for adolescents with low adherence or key health drivers related to adherence. A one-month washout and one-month baseline period will be followed by two stages. In Stage 1 (1 month), patients will be randomized to receive an mHealth asthma management app providing education and automated digital medication reminders (control) or individualized adherence feedback via text messaging based on real-time adherence monitoring (Asthma Ctrl; treatment). At the beginning of Stage 2 (two months), patients randomized to treatment who do not achieve adherence > 68% (non-responders) will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with problem-solving skills training via telehealth. Thus, there are three intervention strategies embedded in this SMART: #1 control, #2 treatment, and #3 adaptive treatment (intervention appropriate to patients’ response to initial treatment). The primary outcome is electronically monitored adherence. Secondary outcomes include asthma control/severity, lung function, and healthcare utilization. If the aims of the project are achieved, this study would have a large impact on pediatric asthma, with the potential to change clinical practice for treating non-adherence. The SMART design will also allow us to identify patients who are most likely to respond to interventions and assess treatment response to allow us to efficiently deliver the right care to the right patient at the right time in the future.