Current Projects
eACT is focused on helping kids with epilepsy and their families learn strategies to help them take their epilepsy medicine on a regular basis.
Epilepsy Adherence in Children with Technology (eACT)
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 a 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
- 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.
Our goal is for children with epilepsy and their families to have the best quality of life possible.
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.
Project Details
- More Information: To learn more about the eACT study, follow this link.
- Collaborators: To hear from study collaborator, Matt Schmidt, PhD, University of Florida, follow this link.
- Funding: R01NR017794-01A; Fostering medication adherence in children with epilepsy using mHealth technology.
- Outcomes and Publications
- Modi, AC; Patel, AD; Stevens, J; Smith, G; Huszti, H; Guilfoyle, SM; Mara, CA; Schmidt, M; Wagner, JL. The psychosocial impact of COVID-19 within the first six months of the pandemic on youth with epilepsy and their caregivers. Epilepsy Behav. 2021 Apr;117:107855.
Diabetes Journey
Our goal is to help teens manage their diabetes so they can have the best quality of life possible.
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. T1D treatment adherence is challenging, especially during adolescence, which can lead to suboptimal blood glucose levels that severely compromises health, and in some cases, leads to premature death.
Several interventions for adolescents with T1D exist, but none have focused on adherence barriers. The Barriers to Diabetes Adherence scale assesses these important targets for tailored adherence interventions, including stress/burnout and time pressure/planning (e.g., skills related to executive functioning). These adherence barriers are significantly associated with non-adherence, higher glycemic levels, and lower quality of life; however, no interventions address these two barriers in research or clinical practice.
We hope the information we learn from teens and their families will improve Type 1 diabetes care for teens across the United States.
The overall objective of this study is to use patient-report of adherence barriers to identify intervention targets that will guide the integration of a novel tailored intervention into clinical care to improve adherence, glycemic levels, and quality of life.
There are several aims of our multi-site R01. First, we plan to reliably integrate patient-reported questionnaires, including the Barriers to Diabetes Adherence scale, into routine care in two, large T1D centers.
Second, our existing intervention, Epilepsy Journey will be modified to Diabetes Journey. This intervention includes mobile health modules addressing barriers related to stress/burnout and time pressure/planning with accompanying telemedicine sessions with a therapist. We will use expert feedback to modify the modules and then conduct usability testing with 10 adolescents with T1D to ensure the modules are easy to navigate, engaging, and relevant to teens with T1D.
Third, we will conduct a pilot clinical trial of Diabetes Journey. Our goal is to evaluate how well Diabetes Journey helps to improve stress/burnout and time pressure/planning (e.g., executive functioning) in 256 adolescents with T1D and whether adolescents think Diabetes Journey is helpful and acceptable. Adolescents who experience elevated adherence barriers during routine T1D clinic visits will be randomized to:
- Diabetes Journey
- Enhanced standard of care (e.g., website and 4 Zoom sessions with a certified diabetes educator)
Both interventions will be tailored to each adolescent’s reported barrier(s). We will also examine the impact of Diabetes Journey on adherence, glycemic control, and quality of life. We are currently actively recruiting participants for the RCT.
Project Details
- More Information: To learn more about the Diabetes Journey study, follow this link.
- Collaborators: Kimberly Driscoll, PhD, University of Florida.
- Funding: R01DK121295; Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents with Type 1 Diabetes
BEAT (Behavioral Economics and Adherence in Teens)
There are no efficacious adherence interventions for adolescents with epilepsy. This gap is remarkable as low motivation and susceptibility to peer influence make adolescents more likely to engage in behaviors that have immediate rewards, especially in the context of their peers (e.g., skipping AEDs when out with friends), and less likely to worry about future negative consequences (e.g., having a seizure).
Not surprisingly, adherence worsens during adolescence, further increasing the risk of poor health outcomes during this developmental period. However, leveraging social norms comparison methods (i.e., feedback about someone else’s behavior related to one’s own behavior) from behavioral economics offers a unique opportunity to capitalize on the increased importance of peer influence, while simultaneously targeting the low motivation characteristic of adolescents.
We are addressing our study aims through an iterative process, including an adolescent focus group (ORBIT Phase 1a: Define; n=8), extended formative usage evaluation (ORBIT Phase 1b: Refine; n=10) and a pilot RCT of the final mHealth social norms intervention (ORBIT Phase II: Pilot; n=138). We have completed Phase 1a and 1b and recruitment for the RCT has been completed. We are currently wrapping up study completion for our ongoing RCT. Data cleaning and analysis will follow.
Project Details
- Funding: R21NR017633-01; Improving Drug Adherence Using mHealth and Behavioral Economics in Adolescents with Epilepsy
