Behavioral Economics and Adherence in Teens (BEAT!)

Not Applicable

Completed

Conditions: Adherence, Medication
Epilepsy

Interventions: Behavioral: Automated Digital Reminders
Behavioral: Individual Adherence Feedback Report with Social Norms
Behavioral: Individualized Adherence Feedback Report

Registration Number: NCT03958331

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary: Non-adherence to antiepileptic drug therapy is a significant problem for adolescents with epilepsy and has a critical impact on health and patient-reported outcomes. Evidence-based adherence interventions are lacking in this population and are critically needed. This proposal seeks to develop and evaluate a mHealth social norms adherence intervention for adolescents with epilepsy.

Detailed Description: Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for youth with epilepsy, with potentially devastating consequences. Adolescents with epilepsy represent a particularly vulnerable group, given their increased independence, decreased parental supervision, higher risk for deficits in organization and memory, busy and changing schedules, low motivation, and increased susceptibility to peer influence. Existing adherence interventions in epilepsy are not designed to meet the unique challenges faced by adolescents, and there are no efficacious interventions for adolescents with epilepsy. Not surprisingly, without efficacious interventions, adherence worsens during adolescence, further increasing the risk of poor health outcomes during this developmental period. While reminder strategies (e.g., automated digital reminders) are effective for the most common adherence barriers of forgetting and busy schedules, they are likely to be ineffective in increasing motivation. Leveraging social norms comparison methods (i.e., feedback about someone else's behavior related to one's own behavior) offers an opportunity to capitalize on the increased importance of peer influence while simultaneously targeting the low motivation characteristic of adolescents. Recent data in adolescents indicates that social norms interventions have incremental value and improve health behaviors above and beyond standard feedback without peer comparisons. Consistent with the ORBIT model for behavioral intervention development, our aims are to: 1) develop a feasible, accessible, and acceptable mHealth social norms intervention for improving AED adherence in adolescents with epilepsy and 2) obtain preliminary efficacy data and effect sizes for a future clinical trial. We conducted a pilot RCT of an mHealth social norms intervention (ORBIT Phase II). Adolescents with epilepsy who demonstrate non-adherence (\< 95% adherence based on PI's previous RCTs; 58% of sample) during baseline will be randomized to either 1) mHealth social norms (automated digital reminders, individualized adherence feedback, and social norms feedback) or 2) control (automated digital reminders and individualized adherence feedback). Both groups will receive active intervention for five months. Primary (i.e., electronically-monitored adherence) and secondary outcomes (i.e., seizure severity, HRQOL) will be assessed post-treatment and 3 months later, respectively. If successful, the results of this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence by reducing common barriers to behavioral health care. Because minimal clinician time is required, our mHealth social norms intervention also has potential for sustainability and broad dissemination for epilepsy and other pediatric conditions

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 104

Inclusion Criteria

Ages 13-17
Confirmed diagnosis of epilepsy
Antiepileptic drug monotherapy
Ability to read and speak English

Exclusion Criteria

No significant developmental delay (e.g., autism, moderate/severe developmental or intellectual disability) or comorbid medical diagnoses (e.g., diabetes)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Automated Digital Reminders	Automated reminders and individualized adherence feedback reports
Treatment Group	Automated Digital Reminders	Automated reminders and individualized adherence feedback reports with social norms comparisons
Treatment Group	Individual Adherence Feedback Report with Social Norms	Automated reminders and individualized adherence feedback reports with social norms comparisons
Control Group	Individualized Adherence Feedback Report	Automated reminders and individualized adherence feedback reports

Primary Outcome Measures

Name	Time	Method
Electronically Monitored Adherence	Month 7	A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence.

Secondary Outcome Measures

Name	Time	Method
Seizure Severity-Clinician Report	Month 9	The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of seizure severity. The total score ranges from 1-7, with higher scores representing more severe epilepsy
Seizure Severity-Parent Report	Month 9	The Seizure Severity Scale-Adapted for Children is a caregiver-reported questionnaire, which is 9-items and assess seizure severity, including intrusiveness, frequency, length, and disruptiveness of seizures. A total score is calculated, ranging from 0-3, with higher scores representing worse seizure severity.
PedsQL Epilepsy Module - Parent Report	Month 9	The PedsQL-Epilepsy Module is a 29 item measure with several subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior) will be used. Scores range from 0-100 for each subscale, with higher scores representing better quality of life.
PedsQL Epilepsy Module-Adolescent Report	9-month	The PedsQL Epilepsy Module is a 29-item health-related quality of life instrument with five subscales, including Impact, Cognitive, Executive Functioning, Sleep, and Mood/Behavior). Scores range from 0-100, with higher scores representing better quality of life.