N/A
N=104
Behavioral Economics and Adherence in Teens (BEAT!)
Epilepsy · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT03958331 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Electronically Monitored Adherence — 45.5; 50.5 units on a scale — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Automated Digital Reminders (Behavioral); Individualized Adherence Feedback Report (Behavioral); Individual Adherence Feedback Report with Social Norms (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electronically Monitored Adherence |
45.5; 50.5 | 0.002 sig |
| SECONDARY Seizure Severity-Clinician Report |
2.5; 2.4 | — |
| SECONDARY Seizure Severity-Parent Report |
0.98; 1.11 | — |
| SECONDARY PedsQL Epilepsy Module - Parent Report |
83.3; 78.8; 63.1; 72.4; 60.3; 65.1 | — |
| SECONDARY PedsQL Epilepsy Module-Adolescent Report |
80; 82.8; 73.6; 71.6; 56.9; 67.7 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03958331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.