Epilepsy Adherence in Children and Technology (eACT)

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.

Conditions

• Epilepsy

Interventions

BEHAVIORAL

Education microlearning sessions

mHealth education microlearning sessions

BEHAVIORAL

Automated digital reminders

reminders from electronic monitors based on texts or lights/chimes

BEHAVIORAL

Problem-solving mHealth module

mhealht problem solving module with 2 telehealth sessions with a therapist

BEHAVIORAL

Individualized Adherence Feedback Report

Individual Adherence Feedback reports sent to parents weekly

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Medical University of South Carolina

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• North Carolina State University

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Avani Modi, Ph.D. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-15

Primary Completion

2024-06-15

Completion

2024-08-01

Countries

• United States

Study Locations