Epilepsy Adherence in Children and Technology (eACT)
eACT
Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology
2 other identifiers
interventional
268
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedResults Posted
Study results publicly available
October 30, 2025
CompletedOctober 30, 2025
September 1, 2025
5.2 years
December 27, 2018
June 2, 2025
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-seizure Medication Adherence Rate
Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome to calculate an adherence rate. A monthly adherence rate for antiseizure medication is calculated for Month 5, which ranges from 0-100%, with higher scores reflecting higher adherence.
Stage 1 (Month 5)
Secondary Outcomes (21)
Antiseizure Medication Adherence Rate
Month 8
Antiseizure Medication Adherence Rate
Month 7 (Stage 2)
Global Assessment of Severity of Epilepsy
Months 8-13
PedsQL Epilepsy Module-Impact (Parent Report)
Month 8
Seizure Severity Adapted for Children Scale-Total Score
Month 8
- +16 more secondary outcomes
Study Arms (3)
Control Group
ACTIVE COMPARATORmHealth education module and automated digital reminders
Treatment Group-Individualized Feedback Only
EXPERIMENTALmHealth education module, automated digital reminders, and individualized adherence feedback.
Treatment Group-Individualized Feedback + Problem-Solving
EXPERIMENTALmHealth education module, automated digital reminders, individualized adherence feedback, and 2 problem solving sessions with a therapist.
Interventions
mHealth education microlearning sessions
reminders from electronic monitors based on texts or lights/chimes
mhealht problem solving module with 2 telehealth sessions with a therapist
Individual Adherence Feedback reports sent to parents weekly
Eligibility Criteria
You may qualify if:
- Children ages 2-12 years
- Epilepsy diagnosis \< 2 years
- Ability to read/speak English
You may not qualify if:
- Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)
- Plan to wean AEDs for 18 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- National Institute of Nursing Research (NINR)collaborator
- Medical University of South Carolinacollaborator
- Children's Hospital of Orange Countycollaborator
- University of Cincinnaticollaborator
- Nationwide Children's Hospitalcollaborator
- North Carolina State Universitycollaborator
Study Sites (4)
Childrens Hospital of Orange County
Orange, California, 92868, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
Wagner JL, Patel AD, Huszti H, Schmidt M, Smith G, Bhatia S, Guilfoyle SM, Lang A, Buschhaus S, Williams S, Ardo J, Davidian M, Modi AC. The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy. Contemp Clin Trials. 2024 Dec;147:107739. doi: 10.1016/j.cct.2024.107739. Epub 2024 Nov 10.
PMID: 39532238DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Health utilization data were not analyzed as the trial took place during the COVID-19 pandemic which affected the comfort of participants going to their emergency room departments and/or inpatient hospitalizations.
Results Point of Contact
- Title
- Avani Modi, Ph.D.
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Avani Modi, Ph.D.
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Masking Details
- The PI will not be notified of group status or details of participants. The healthcare provider will also not know which group participants are randomized to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2018
First Posted
January 25, 2019
Study Start
April 15, 2019
Primary Completion
June 15, 2024
Study Completion
August 1, 2024
Last Updated
October 30, 2025
Results First Posted
October 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- 12 months after completion of the study
- Access Criteria
- Requested from the PI
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.