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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017794-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Medical University of South Carolina | OTHER |
| Children's Hospital of Orange County | OTHER |
| University of Cincinnati |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | mHealth education module and automated digital reminders |
|
| Treatment Group-Individualized Feedback Only | Experimental | mHealth education module, automated digital reminders, and individualized adherence feedback. |
|
| Treatment Group-Individualized Feedback + Problem-Solving | Experimental | mHealth education module, automated digital reminders, individualized adherence feedback, and 2 problem solving sessions with a therapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education microlearning sessions | Behavioral | mHealth education microlearning sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 8 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avani Modi, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Orange County | Orange | California | 92868 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39532238 | Derived | 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. |
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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.
12 months after completion of the study
Requested from the PI
Not provided
Following recruitment, participants were in a run-in period of 2 months. All participants who demonstrated adherence > 95% ended study participation at the end of the 2-month run-in period and were ineligible for randomization.
Participants were recruited from four sites: Cincinnati Children's Hospital Medical Center, Medical University of South Carolina, Children's Hospital of Orange County, and Nationwide Children's Hospital. Participants were recruited through epilepsy clinics from April 2019-September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | mHealth education module and automated digital reminders Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes |
| FG001 | Treatment Group (E+ADR+IAF in Stage 1 and remained in Stage 2) | 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). These were participants in the treatment group demonstrate adherence > 95%, and continued with the treatment arm of receiving automated digital reminders and individualized adherence feedback. Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes Individualized Adherence Feedback Report: Individual Adherence Feedback reports sent to parents weekly |
| FG002 | Treatment Group (E+ADR+IAF) non-responsive but continue IAF | 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). These participants were considered non-responsive (adherence \ |
| FG003 | Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | 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). These participants were considered non-responsive (adherence \ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period-Stage 1 |
|
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| Intervention Period-Stage 2 |
| |||||||||||||||||||
| Post-Intervention |
| |||||||||||||||||||
| Follow-up 1 |
| |||||||||||||||||||
| Follow-up 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | mHealth education module and automated digital reminders Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes |
| BG001 | Treatment Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Stage 1 (Month 5) |
|
20 months
The Stage 1 non-responsive group is divided into two groups in Stage 2: 1) Treatment Group (E+ADR+IAF) Non-responsive But Continue IAF and 2) Treatment Group (E+ADR+IAF+PS) Non-responsive and PS Added. Thus, we did not present the combined Stage 1 data as they are reported separately and would redundant. n=12 participants withdrew from the study during Stage 1 treatment and thus were excluded from these data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | mHealth education module and automated digital reminders Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical complications not related to epilepsy | Blood and lymphatic system disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avani Modi, Ph.D. | Cincinnati Children's Hospital Medical Center | 5136364864 | avani.modi@cchmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2023 | May 8, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2025 | May 30, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Apr 29, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
| OTHER |
| Nationwide Children's Hospital | OTHER |
| North Carolina State University | OTHER |
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.
Not provided
Not provided
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.
| Automated digital reminders | Behavioral | reminders from electronic monitors based on texts or lights/chimes |
|
| Problem-solving mHealth module | Behavioral | mhealht problem solving module with 2 telehealth sessions with a therapist |
|
| Individualized Adherence Feedback Report | Behavioral | Individual Adherence Feedback reports sent to parents weekly |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Months 8-14 |
| 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 |
| Withdrawn by Study Team |
|
| Weaned from medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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. Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes Problem-solving mHealth module: mhealht problem solving module with 2 telehealth sessions with a therapist Individualized Adherence Feedback Report: Individual Adherence Feedback reports sent to parents weekly |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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).
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Individualized Adherence Feedback Report: Individual Adherence Feedback reports sent to parents weekly
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 7 (Stage 2) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Months 8-13 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Months 8-11 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Months 14-19 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Month 14-17 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | number of emergency room visits | Months 8-14 |
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| Secondary | Hospitalizations (Healthcare Utilization) | Number of inpatient hospitalization based on medical chart review and caregiver report. Higher numbers mean a higher level of inpatient hospitalizations. | Posted | Mean | Standard Deviation | number of inpatient hospitalizations | Months 8-14 |
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| 0 |
| 89 |
| 0 |
| 89 |
| 35 |
| 89 |
| EG001 | Treatment Group (E+ADR+IAF in Stage 1 and remained in Stage 2) | 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). These were participants in the treatment group demonstrate adherence > 95%, and continued with the treatment arm of receiving automated digital reminders and individualized adherence feedback. Education microlearning sessions: mHealth education microlearning sessions Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes Individualized Adherence Feedback Report: Individual Adherence Feedback reports sent to parents weekly | 0 | 48 | 0 | 48 | 13 | 48 |
| EG002 | Treatment Group (E+ADR+IAF) non-responsive but continue IAF | 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). These participants were considered non-responsive (adherence \ | 0 | 56 | 1 | 56 | 24 | 56 |
| EG003 | Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | 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). These participants were considered non-responsive (adherence \ | 0 | 63 | 0 | 63 | 21 | 63 |
| Medical complications not related to epilepsy | Cardiac disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Ear and labyrinth disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Gastrointestinal disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | General disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Hepatobiliary disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Immune system disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Infections and infestations | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Product Issues | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Reproductive system and breast disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Medical complications not related to epilepsy | Surgical and medical procedures | Non-systematic Assessment |
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| Planned Inpatient/Outpatient Procedures Not Related to Epilepsy | Investigations | Non-systematic Assessment |
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| Planned Inpatient/Outpatient Procedures Not Related to Epilepsy | Surgical and medical procedures | Non-systematic Assessment |
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| Medical complications related to epilepsy | Nervous system disorders | Non-systematic Assessment |
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| Planned Inpatient/Outpatient Procedures Related to Epilepsy | Surgical and medical procedures | Non-systematic Assessment |
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| Psychological Complications | Psychiatric disorders | Non-systematic Assessment |
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Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |