Epilepsy Adherence in Children with Technology (eACT)
(R01NR017794-01A; Fostering medication adherence in children with epilepsy using mHealth technology)
Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for young children with newly diagnosed epilepsy, with potentially devastating consequences. AED non-adherence is associated with a 3-fold increased risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher healthcare utilization and costs.
One of the primary barriers to adherence is forgetting, which may be particularly amenable to mHealth (mobile technology in healthcare) interventions. Despite the critical need to develop and implement interventions to improve adherence, there are few family-based interventions for young children with epilepsy and their families, with the exception of our work.
Although highly promising, this intervention requires six in-person sessions, which can be impossible for families who lack routine access to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet medical and psychosocial needs of the underserved pediatric epilepsy population are perpetuated and compounded by limited access to this state-of-the-art care.
Our overall goal in this multisite study is to test an mHealth adherence intervention that is easily accessible using a stepped up care model based on individual needs. This stepped up care model will conserve patient, family, and provider time, costs and resources. We have completed the first phase of this work and incorporated the feedback we gathered from caregivers during focus groups and usability studies to develop education microlearning sessions, automated digital reminders, individualized adherence feedback reports to improve adherence, and telehealth problem-solving sessions.
The second phase of this study will consist of a 2-stage, sequential, multiple-assignment, randomized trial (SMART) to evaluate the effectiveness of mHealth intervention strategies for improving AED adherence in parents/legal guardians of young children with epilepsy. We plan to recruit a total of 600 participants across all collaborating study sites, with approximately 150 at each of four sites (Cincinnati Children’s, Medical University of South Carolina, Children’s Hospital of Orange County, and Nationwide Children’s Hospital). Enrolled caregivers will complete study questionnaires and be asked to start using electronic adherence monitors (e.g., pillbox or pill bottle) at the time of data enrollment during the baseline period. Only participants who demonstrate adherence <95% will be randomized to either the control group or treatment group in Stage 1. n SMART Stage 1 (3-months), caregivers of non-adherent children (< 95%) are randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting.
At the beginning of SMART Stage 2, caregivers randomized to the treatment group who demonstrate continued non-adherence (<95%; non-response) by the end of Stage 1 undergo a second randomization to either 1) continued individualized adherence feedback or 2) individualized adherence feedback augmented with a mHealth problem-solving module (translated from the PIs existing RCTs) and two therapist-guided Skype sessions. The primary outcome is electronically monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization. These data will then be examined, analyzed, and used to evaluate study aims including efficacy, effectiveness, and predictors of treatment responsiveness.
Learn more about this research from collaborator Matt Schmidt, PhD, University of Florida.