N/A N=268 Randomized Double-blind Treatment

Epilepsy Adherence in Children and Technology (eACT)

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT03817229 ↗

Enrolled (actual)

268

Serious AEs

0.4%

Results posted

Oct 2025

Primary outcome: Primary: Anti-seizure Medication Adherence Rate — 68.93; 77.23 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Education microlearning sessions (Behavioral); Automated digital reminders (Behavioral); Problem-solving mHealth module (Behavioral); Individualized Adherence Feedback Report (Behavioral)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-seizure Medication Adherence Rate	68.93; 77.23	—
SECONDARY Antiseizure Medication Adherence Rate	50.26; 72.76; 43.26; 59.02	—
SECONDARY Antiseizure Medication Adherence Rate	50.26; 72.76; 43.26; 59.02	—
SECONDARY Global Assessment of Severity of Epilepsy	0.19; 0.18; 0.35; 0.35	—
SECONDARY PedsQL Epilepsy Module-Impact (Parent Report)	82.2; 82.14; 82.03; 85.19	—
SECONDARY Seizure Severity Adapted for Children Scale-Total Score	0.84; 0.87; 0.81; 0.64	—
SECONDARY Seizure Freedom	0.69; 0.64; 0.55; 0.64	—
SECONDARY Antiseizure Medication Adherence Rate	50.26; 72.76; 43.26; 59.02	—
SECONDARY Global Assessment of Severity of Epilepsy	0.19; 0.18; 0.35; 0.35	—
SECONDARY PedsQL Epilepsy Module-Impact (Parent Report)	82.2; 82.14; 82.03; 85.19	—
SECONDARY PedsQL Epilepsy Module-Cognition (Parent Report)	61.90; 69.20; 63.85; 65.03	—
SECONDARY PedsQL Epilepsy Module-Cognition (Parent Report)	61.90; 69.20; 63.85; 65.03	—
SECONDARY PedsQL Epilepsy Module-Sleep (Parent Report)	54.53; 57.76; 62.01; 61.53	—
SECONDARY PedsQL Epilepsy Module-Sleep (Parent Report)	54.53; 57.76; 62.01; 61.53	—
SECONDARY PedsQL Epilepsy Module-Executive Functioning (Parent Report)	55.27; 59.05; 58.54; 57.71	—
SECONDARY PedsQL Epilepsy Module-Executive Functioning (Parent Report)	55.27; 59.05; 58.54; 57.71	—
SECONDARY PedsQL Epilepsy Module-Mood/Behavior (Parent Report)	63.08; 74.44; 69.62; 69.12	—
SECONDARY PedsQL Epilepsy Module-Mood/Behavior (Parent Report)	63.08; 74.44; 69.62; 69.12	—
SECONDARY Seizure Freedom	0.69; 0.64; 0.55; 0.64	—
SECONDARY Seizure Severity Adapted for Children Scale-Total Score	0.84; 0.87; 0.81; 0.64	—
SECONDARY Emergency Room and Urgent Care Visits Combined	0.33; 0.12; 0.28; 0.32	—
SECONDARY Hospitalizations (Healthcare Utilization)	0.13; 0.17; 0.30; 0.32	—

Summary

Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. Evidence-based adherence interventions are lacking and critically needed, especially for children with epilepsy, who represent an underserved population in pediatrics. The current proposal is a mHealth sequential, multiple assignment, randomized trial (SMART) focused on providing education, automated digital reminders, and individualized adherence feedback, as well as teaching problem-solving skills, with the goal of improving adherence and quality of life and decreasing seizures and health care utilization.

Eligibility Criteria

Inclusion criteria

Children ages 2-12 years
Epilepsy diagnosis < 2 years
Ability to read/speak English

Exclusion criteria

Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)
Plan to wean AEDs for 18 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03817229). 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.