EpilepsyeACTNCT03817229
Epilepsy Adherence in Children and Technology (eACT)
A study testing Education microlearning sessions, Automated digital reminders and Problem-solving mHealth module in people with Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Education microlearning sessions, Automated digital reminders and Problem-solving mHealth module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2019to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 2-12 years
- Epilepsy diagnosis < 2 years
- Ability to read/speak English
Who cannot join
- Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)
- Plan to wean AEDs for 18 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Childrens Hospital of Orange County
Orange, California, 92868
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Education microlearning sessions, Automated digital reminders, Problem-solving mHealth module, Individualized Adherence Feedback Report
- Keywords
- adherence, mHealth, eHealth, children, caregivers, compliance
- Medical subject headings
- Epilepsy, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education microlearning sessionsBehavioural
mHealth education microlearning sessions
Automated digital remindersBehavioural
reminders from electronic monitors based on texts or lights/chimes
Problem-solving mHealth moduleBehavioural
mhealht problem solving module with 2 telehealth sessions with a therapist
Individualized Adherence Feedback ReportBehavioural
Individual Adherence Feedback reports sent to parents weekly
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | mHealth education module and automated digital reminders Receives: Behavioral: Education microlearning sessions; Behavioral: Automated digital reminders |
| Treatment Group-Individualized Feedback Only | Experimental | mHealth education module, automated digital reminders, and individualized adherence feedback. Receives: Behavioral: Education microlearning sessions; Behavioral: Automated digital reminders; Behavioral: Individualized Adherence Feedback Report |
| Treatment Group-Individualized Feedback + Problem-Solving | Experimental | mHealth education module, automated digital reminders, individualized adherence feedback, and 2 problem solving sessions with a therapist. Receives: Behavioral: Education microlearning sessions; Behavioral: Automated digital reminders; Behavioral: Problem-solving mHealth module; Behavioral: Individualized Adherence Feedback Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Stage 1 (Month 5)
Secondary outcomes (21)
Antiseizure Medication Adherence Rate
lectronically 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 8, which ranges from 0-100%, with higher scores reflecting higher adherence.
Measured: Month 8
Antiseizure Medication Adherence Rate
lectronically 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 7, which ranges from 0-100%, with higher scores reflecting higher adherence.
Measured: Month 7 (Stage 2)
Global Assessment of Severity of Epilepsy
The GASE is a item measure, ranging from 1-7, with 7 representing worse seizure severity. GASE was dichotomized with a 0 or 1 rating. Participants who received a GASE severity score of 1 or 2 were given a 0 score and those who received a GASE score of 3-7 were given a 1 score. In this context, a GASE category of 0 is the lower severity rating.
Measured: Months 8-13
PedsQL Epilepsy Module-Impact (Parent Report)
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.
Measured: Month 8
Seizure Severity Adapted for Children Scale-Total Score
Seizure Severity Scale Adapted for Children is a measure of seizure severity via parent-report. This caregiver questionnaire is nine-items assessing the child's seizure severity. Items focus on the intrusiveness, frequency, length, and disruptiveness of seizures. Items are scored from 0-3 and a mean is calculated across items for a Total score. Higher scores reflect greater seizure severity.
Measured: Month 8
Seizure Freedom
Seizure Freedom is a dichotomous variable regarding the absence or presence of seizures over a 4 month period of time. Participants were given a score of 0 if they had no seizures and a score of 1 if they had any seizures during that time frame. Thus, a score of 0 represents seizure freedom while a score of 1 represents the presence of seizures.
Measured: Months 8-11
Antiseizure Medication Adherence Rate
lectronically 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 14, which ranges from 0-100%, with higher scores reflecting higher adherence.
Measured: Month 14
Global Assessment of Severity of Epilepsy
The GASE is a item measure, ranging from 1-7, with 7 representing worse seizure severity. GASE was dichotomized with a 0 or 1 rating. Participants who received a GASE severity score of 1 or 2 were given a 0 score and those who received a GASE score of 3-7 were given a 1 score. In this context, a GASE category of 0 is the lower severity rating.
Measured: Months 14-19
PedsQL Epilepsy Module-Impact (Parent Report)
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.
Measured: Month 14
PedsQL Epilepsy Module-Cognition (Parent Report)
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.
Measured: Month 8
PedsQL Epilepsy Module-Cognition (Parent Report)
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.
Measured: Month 14
PedsQL Epilepsy Module-Sleep (Parent Report)
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.
Measured: Month 8
PedsQL Epilepsy Module-Sleep (Parent Report)
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.
Measured: Month 14
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
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.
Measured: Month 8
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
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.
Measured: Month 14
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
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.
Measured: Month 14
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
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.
Measured: Month 8
Seizure Freedom
Seizure Freedom is a dichotomous variable regarding the absence or presence of seizures over a 4 month period of time. Participants were given a score of 0 if they had no seizures and a score of 1 if they had any seizures during that time frame. Thus, a score of 0 represents seizure freedom while a score of 1 represents the presence of seizures.
Measured: Month 14-17
Seizure Severity Adapted for Children Scale-Total Score
Seizure Severity Scale Adapted for Children is a measure of seizure severity via parent-report. This caregiver questionnaire is nine-items assessing the child's seizure severity. Items focus on the intrusiveness, frequency, length, and disruptiveness of seizures. Items are scored from 0-3 and a mean is calculated across items for a Total score. Higher scores reflect greater seizure severity.
Measured: Month 14
Emergency Room and Urgent Care Visits Combined
Emergency Room and Urgent Care Visits Combined (Healthcare utilization) - Number of emergency room visits based on medical chart review and caregiver report. Higher scores reflect more visits.
Measured: Months 8-14
Hospitalizations (Healthcare Utilization)
Number of inpatient hospitalization based on medical chart review and caregiver report. Higher numbers mean a higher level of inpatient hospitalizations.
Measured: Months 8-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Apr 2019
- Primary completion15 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This a 2-stage, sequential, multiple assignment, randomized trial (SMART) . In Stage 1 (three 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 three mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Medical University of South Carolina, Children's Hospital of Orange County, University of Cincinnati, Nationwide Children's Hospital, North Carolina State University
- Responsible party
- Sponsor
- Investigators
- Avani Modi, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817229
- Sponsor's protocol ID
- FP00001781
- Other IDs
- R01NR017794-01A1
- Acronym
- eACT
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2018
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39532238
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology
- ClinicalTrials.gov ID
- NCT03817229
- Acronym / sponsor ID
- eACT / FP00001781
- Conditions
- Epilepsy
- Keywords
- adherence, mHealth, eHealth, children, caregivers, compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Medical University of South Carolina, Children's Hospital of Orange County, University of Cincinnati, Nationwide Children's Hospital, North Carolina State University
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- This a 2-stage, sequential, multiple assignment, randomized trial (SMART) . In Stage 1 (three 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 three mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Education microlearning sessions, Behavioral: Automated digital remindersmHealth education module and automated digital reminders |
| Treatment Group-Individualized Feedback Only | Experimental | Behavioral: Education microlearning sessions, Behavioral: Automated digital reminders, Behavioral: Individualized Adherence Feedback ReportmHealth education module, automated digital reminders, and individualized adherence feedback. |
| Treatment Group-Individualized Feedback + Problem-Solving | Experimental | Behavioral: Education microlearning sessions, Behavioral: Automated digital reminders, Behavioral: Problem-solving mHealth module, Behavioral: Individualized Adherence Feedback ReportmHealth education module, automated digital reminders, individualized adherence feedback, and 2 problem solving sessions with a therapist. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 2-12 years
- Epilepsy diagnosis < 2 years
- Ability to read/speak English
Key exclusion criteria (2 listed)
- Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)
- Plan to wean AEDs for 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education microlearning sessionsmHealth education microlearning sessions | Behavioural | Control Group, Treatment Group-Individualized Feedback + Problem-Solving, Treatment Group-Individualized Feedback Only |
| Automated digital remindersreminders from electronic monitors based on texts or lights/chimes | Behavioural | Control Group, Treatment Group-Individualized Feedback + Problem-Solving, Treatment Group-Individualized Feedback Only |
| Problem-solving mHealth modulemhealht problem solving module with 2 telehealth sessions with a therapist | Behavioural | Treatment Group-Individualized Feedback + Problem-Solving |
| Individualized Adherence Feedback ReportIndividual Adherence Feedback reports sent to parents weekly | Behavioural | Treatment Group-Individualized Feedback + Problem-Solving, Treatment Group-Individualized Feedback Only |
Primary outcome
Anti-seizure Medication Adherence Rate
Time frame: Stage 1 (Month 5)
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.
21 secondary outcomes
Antiseizure Medication Adherence Rate
Time frame: Month 8
Antiseizure Medication Adherence Rate
Time frame: Month 7 (Stage 2)
Global Assessment of Severity of Epilepsy
Time frame: Months 8-13
PedsQL Epilepsy Module-Impact (Parent Report)
Time frame: Month 8
Seizure Severity Adapted for Children Scale-Total Score
Time frame: Month 8
Seizure Freedom
Time frame: Months 8-11
Antiseizure Medication Adherence Rate
Time frame: Month 14
Global Assessment of Severity of Epilepsy
Time frame: Months 14-19
PedsQL Epilepsy Module-Impact (Parent Report)
Time frame: Month 14
PedsQL Epilepsy Module-Cognition (Parent Report)
Time frame: Month 8
PedsQL Epilepsy Module-Cognition (Parent Report)
Time frame: Month 14
PedsQL Epilepsy Module-Sleep (Parent Report)
Time frame: Month 8
PedsQL Epilepsy Module-Sleep (Parent Report)
Time frame: Month 14
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
Time frame: Month 8
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
Time frame: Month 14
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
Time frame: Month 14
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
Time frame: Month 8
Seizure Freedom
Time frame: Month 14-17
Seizure Severity Adapted for Children Scale-Total Score
Time frame: Month 14
Emergency Room and Urgent Care Visits Combined
Time frame: Months 8-14
Hospitalizations (Healthcare Utilization)
Time frame: Months 8-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39532238Wagner 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avani Modi, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education microlearning sessions, Automated digital reminders and Problem-solving mHealth module in people with Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-seizure Medication Adherence Rate (time frame: Stage 1 (Month 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.