Epilepsy Adherence in Children and Technology (eACT) (eACT)

Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Education microlearning sessions; Behavioral: Automated digital reminders; Behavioral: Problem-solving mHealth module; Behavioral: Individualized Adherence Feedback Report

Detailed Description

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 health care 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. One existing intervention is highly promising; however, 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. The overall goal 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. The aim of this multi-site R01 is to conduct a two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of young children with epilepsy. A two-month baseline period will be followed by two stages. In Stage 1 (3-months long), non-adherent caregivers (< 95%) will be 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 Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence > 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with two mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist. Thus, there are three intervention strategies embedded in this SMART: #1 control, #2 treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The primary outcome is electronically-monitored adherence and secondary outcomes include seizure severity/frequency, quality of life, and healthcare utilization. If the aims of the project are achieved, this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence. The SMART design would allow the investigators to identify patients who are most likely to respond to interventions and step up care with more time- and resource-intensive interventions (i.e., problem-solving with a therapist via the web), when necessary.

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avani Modi, Ph.D.; Phone Number: 513-636-4864; Email: avani.modi@cchmc.org
• Study Contact Backup: Name: Leigh Ann Chamberlin; Phone Number: (513) 636-9739; Email: LeighAnn.Chamberlin@cchmc.org

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Childrens Hospital of Orange County
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; mHealth education module and automated digital reminders	Behavioral: Education microlearning sessions; mHealth education microlearning sessions; Behavioral: Automated digital reminders; reminders from electronic monitors based on texts or lights/chimes
Experimental: Treatment Group; mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (> 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence > 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence < 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rates	Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.	Month 8
Adherence rates	Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.	Month 14
Adherence rates	Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.	Month 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in seizure frequency	Change in seizure frequency will be measured via parent-report and medical chart review. Change in seizure frequency will be calculated based on the number of seizures experienced in months 8-14 of the study compared to the 6-month baseline seizure frequency data. Seizure freedom will be a dichotomous variable (yes or no) and based on whether any type of seizure was experienced by the participant in months 8-14.	Months 8-14
PedsQL Epilepsy Module (health-related quality of life measure)	The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.	Month 14
Healthcare utilization (the number of emergency room visits and hospitalizations)	Based on medical chart review and parent report, the total number of emergency room visits and hospitalizations will be counting from Months 8-20 of the study.	Months 8-20

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Medical University of South Carolina; National Institute of Nursing Research (NINR); Nationwide Children's Hospital; University of Cincinnati; Children's Hospital of Orange County; North Carolina State University
• Investigators: Principal Investigator: Avani Modi, Ph.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: adherence; compliance; children; mHealth; caregivers; eHealth
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: FP00001781; R01NR017794-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Prior to sharing, all data will be de-identified in a HIPAA-compliant fashion. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All modalities of data will be shared, including raw and aggregate data. Descriptors for all variables shared will be included to prevent misuse or confusion. Any analytical methods utilized to assess the data will be defined in shared formats. In addition, treatment manuals related to problem-solving and mHealth modules will also be shared after completion of the trial for future use.
• IPD Sharing Time Frame: 12 months after completion of the study
• IPD Sharing Access Criteria: Requested from the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No