Epilepsy
Conditions
Keywords
adherence, mHealth, eHealth, children, caregivers, compliance
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.
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.
Interventions
BEHAVIORALEducation microlearning sessions
mHealth education microlearning sessions
BEHAVIORALAutomated digital reminders
reminders from electronic monitors based on texts or lights/chimes
BEHAVIORALProblem-solving mHealth module
mhealht problem solving module with 2 telehealth sessions with a therapist
BEHAVIORALIndividualized Adherence Feedback Report
Individual Adherence Feedback reports sent to parents weekly
Sponsors
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
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children ages 2-12 years 2. Epilepsy diagnosis \< 2 years 3. Ability to read/speak English
Exclusion criteria
1. Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes) 2. Plan to wean AEDs for 18 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-seizure Medication Adherence Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | Month 14 | 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. |
| Seizure Freedom | Month 14-17 | 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. |
| Seizure Severity Adapted for Children Scale-Total Score | Month 14 | 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. |
| Emergency Room and Urgent Care Visits Combined | Months 8-14 | 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. |
| Hospitalizations (Healthcare Utilization) | Months 8-14 | Number of inpatient hospitalization based on medical chart review and caregiver report. Higher numbers mean a higher level of inpatient hospitalizations. |
| PedsQL Epilepsy Module-Executive Functioning (Parent Report) | Month 14 | 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. |
| Global Assessment of Severity of Epilepsy | Months 8-13 | 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. |
| PedsQL Epilepsy Module-Impact (Parent Report) | Month 8 | 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. |
| PedsQL Epilepsy Module-Cognition (Parent Report) | Month 8 | 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. |
| PedsQL Epilepsy Module-Sleep (Parent Report) | Month 8 | 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. |
| Antiseizure Medication Adherence Rate | Month 8 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 89 |
| Treatment Group mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (\> 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence \> 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence \< 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.
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 | 179 |
| Total | 268 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-up 1 | Ineligible for this follow-up visit due to study timing | 7 | 4 | 4 | 3 |
| Follow-up 1 | Transferred care to another hospital | 1 | 0 | 0 | 0 |
| Follow-up 1 | Wean from medication | 3 | 4 | 0 | 1 |
| Follow-up 1 | Withdrawal by Study Team | 3 | 1 | 0 | 0 |
| Follow-up 1 | Withdrawal by Subject | 1 | 2 | 0 | 0 |
| Follow-up 2 | Ineligible for this follow-up visit due to study timing | 4 | 3 | 1 | 4 |
| Follow-up 2 | Transferred care | 0 | 0 | 1 | 0 |
| Follow-up 2 | Wean from medication | 1 | 0 | 0 | 0 |
| Follow-up 2 | Withdrawal by Study Team | 2 | 0 | 1 | 0 |
| Follow-up 2 | Withdrawal by Subject | 2 | 0 | 1 | 1 |
| Intervention Period-Stage 1 | Weaned from medication | 0 | 3 | 0 | 0 |
| Intervention Period-Stage 1 | Withdrawal by Subject | 6 | 8 | 0 | 0 |
| Intervention Period-Stage 1 | Withdrawn by Study Team | 0 | 1 | 0 | 0 |
| Intervention Period-Stage 2 | Weaned from medication | 0 | 0 | 0 | 1 |
| Intervention Period-Stage 2 | Withdrawal by Study Team | 0 | 0 | 0 | 3 |
| Intervention Period-Stage 2 | Withdrawal by Subject | 1 | 0 | 1 | 10 |
| Post-Intervention | Change in parental guardianship | 0 | 0 | 1 | 0 |
| Post-Intervention | Transferred care to another institution | 1 | 0 | 0 | 0 |
| Post-Intervention | Weaned from medication | 3 | 0 | 2 | 1 |
| Post-Intervention | Withdrawal by Study Team | 3 | 1 | 1 | 4 |
| Post-Intervention | Withdrawal by Subject | 6 | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Control Group | Total | Treatment Group |
|---|---|---|---|
| Age, Continuous | 7.4 years STANDARD_DEVIATION 3.1 | 7.4 years STANDARD_DEVIATION 3 | 7.4 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 51 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 217 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 31 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 25 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 11 Participants | 10 Participants |
| Race (NIH/OMB) White | 69 Participants | 185 Participants | 116 Participants |
| Region of Enrollment United States | 89 participants | 268 participants | 179 participants |
| Sex: Female, Male Female | 44 Participants | 140 Participants | 96 Participants |
| Sex: Female, Male Male | 45 Participants | 128 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 48 | 0 / 56 | 0 / 63 |
| other Total, other adverse events | 35 / 89 | 13 / 48 | 24 / 56 | 21 / 63 |
| serious Total, serious adverse events | 0 / 89 | 0 / 48 | 1 / 56 | 0 / 63 |
Outcome results
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.
Time frame: Stage 1 (Month 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Anti-seizure Medication Adherence Rate | 68.93 score on a scale | Standard Deviation 35.65 |
| Treatment Group (E+ADR+IAF) | Anti-seizure Medication Adherence Rate | 77.23 score on a scale | Standard Deviation 27.29 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Antiseizure Medication Adherence Rate | 58.80 score on a scale | Standard Deviation 32.29 |
| Treatment Group (E+ADR+IAF) | Antiseizure Medication Adherence Rate | 74.42 score on a scale | Standard Deviation 32.02 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Antiseizure Medication Adherence Rate | 48.87 score on a scale | Standard Deviation 33.27 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Antiseizure Medication Adherence Rate | 54.76 score on a scale | Standard Deviation 34.98 |
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.
Time frame: Month 7 (Stage 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Antiseizure Medication Adherence Rate | 71.68 score on a scale | Standard Deviation 31.99 |
| Treatment Group (E+ADR+IAF) | Antiseizure Medication Adherence Rate | 91.66 score on a scale | Standard Deviation 14.98 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Antiseizure Medication Adherence Rate | 68.52 score on a scale | Standard Deviation 25.93 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Antiseizure Medication Adherence Rate | 79.71 score on a scale | Standard Deviation 23.05 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Antiseizure Medication Adherence Rate | 50.26 score on a scale | Standard Deviation 33.46 |
| Treatment Group (E+ADR+IAF) | Antiseizure Medication Adherence Rate | 72.76 score on a scale | Standard Deviation 36.16 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Antiseizure Medication Adherence Rate | 43.26 score on a scale | Standard Deviation 31.72 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Antiseizure Medication Adherence Rate | 59.02 score on a scale | Standard Deviation 31 |
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.
Time frame: Months 8-14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Emergency Room and Urgent Care Visits Combined | 0.33 number of emergency room visits | Standard Deviation 0.84 |
| Treatment Group (E+ADR+IAF) | Emergency Room and Urgent Care Visits Combined | 0.12 number of emergency room visits | Standard Deviation 0.4 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Emergency Room and Urgent Care Visits Combined | 0.28 number of emergency room visits | Standard Deviation 0.55 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Emergency Room and Urgent Care Visits Combined | 0.32 number of emergency room visits | Standard Deviation 0.63 |
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.
Time frame: Months 8-13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Global Assessment of Severity of Epilepsy | 0.28 units on a scale | Standard Deviation 0.45 |
| Treatment Group (E+ADR+IAF) | Global Assessment of Severity of Epilepsy | 0.25 units on a scale | Standard Deviation 0.44 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Global Assessment of Severity of Epilepsy | 0.33 units on a scale | Standard Deviation 0.47 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Global Assessment of Severity of Epilepsy | 0.24 units on a scale | Standard Deviation 0.43 |
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.
Time frame: Months 14-19
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Global Assessment of Severity of Epilepsy | 0.19 units on a scale | Standard Deviation 0.39 |
| Treatment Group (E+ADR+IAF) | Global Assessment of Severity of Epilepsy | 0.18 units on a scale | Standard Deviation 0.39 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Global Assessment of Severity of Epilepsy | 0.35 units on a scale | Standard Deviation 0.48 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Global Assessment of Severity of Epilepsy | 0.35 units on a scale | Standard Deviation 0.49 |
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.
Time frame: Months 8-14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Hospitalizations (Healthcare Utilization) | 0.13 number of inpatient hospitalizations | Standard Deviation 0.47 |
| Treatment Group (E+ADR+IAF) | Hospitalizations (Healthcare Utilization) | 0.17 number of inpatient hospitalizations | Standard Deviation 0.38 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Hospitalizations (Healthcare Utilization) | 0.30 number of inpatient hospitalizations | Standard Deviation 0.47 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Hospitalizations (Healthcare Utilization) | 0.32 number of inpatient hospitalizations | Standard Deviation 0.63 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Cognition (Parent Report) | 62.15 score on a scale | Standard Deviation 27.43 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Cognition (Parent Report) | 68.89 score on a scale | Standard Deviation 27.74 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Cognition (Parent Report) | 63.56 score on a scale | Standard Deviation 28.51 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Cognition (Parent Report) | 64.35 score on a scale | Standard Deviation 29.68 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Cognition (Parent Report) | 61.90 score on a scale | Standard Deviation 27.11 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Cognition (Parent Report) | 69.20 score on a scale | Standard Deviation 25.97 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Cognition (Parent Report) | 63.85 score on a scale | Standard Deviation 26.66 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Cognition (Parent Report) | 65.03 score on a scale | Standard Deviation 30.09 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 51.70 score on a scale | Standard Deviation 28.51 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 63.80 score on a scale | Standard Deviation 24.43 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 56.46 score on a scale | Standard Deviation 30.4 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 59.43 score on a scale | Standard Deviation 28.58 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 55.27 score on a scale | Standard Deviation 32.87 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 59.05 score on a scale | Standard Deviation 27.56 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 58.54 score on a scale | Standard Deviation 27.98 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Executive Functioning (Parent Report) | 57.71 score on a scale | Standard Deviation 29.69 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Impact (Parent Report) | 78.76 score on a scale | Standard Deviation 18.25 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Impact (Parent Report) | 81.67 score on a scale | Standard Deviation 18.52 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Impact (Parent Report) | 81.01 score on a scale | Standard Deviation 21.57 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Impact (Parent Report) | 85.07 score on a scale | Standard Deviation 16.52 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Impact (Parent Report) | 82.2 score on a scale | Standard Deviation 16.64 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Impact (Parent Report) | 82.14 score on a scale | Standard Deviation 19.76 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Impact (Parent Report) | 82.03 score on a scale | Standard Deviation 21.82 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Impact (Parent Report) | 85.19 score on a scale | Standard Deviation 14.11 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 63.08 score on a scale | Standard Deviation 21.61 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 74.44 score on a scale | Standard Deviation 17.56 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 69.62 score on a scale | Standard Deviation 19.13 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 69.12 score on a scale | Standard Deviation 22.64 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 61.91 score on a scale | Standard Deviation 20.67 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 70.00 score on a scale | Standard Deviation 18.37 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 64.56 score on a scale | Standard Deviation 19.12 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Mood/Behavior (Parent Report) | 68.50 score on a scale | Standard Deviation 24.88 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Sleep (Parent Report) | 54.53 score on a scale | Standard Deviation 23.44 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Sleep (Parent Report) | 57.76 score on a scale | Standard Deviation 27.09 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Sleep (Parent Report) | 62.01 score on a scale | Standard Deviation 22.49 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Sleep (Parent Report) | 61.53 score on a scale | Standard Deviation 27.28 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PedsQL Epilepsy Module-Sleep (Parent Report) | 51.92 score on a scale | Standard Deviation 25.74 |
| Treatment Group (E+ADR+IAF) | PedsQL Epilepsy Module-Sleep (Parent Report) | 59.07 score on a scale | Standard Deviation 23.78 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | PedsQL Epilepsy Module-Sleep (Parent Report) | 59.27 score on a scale | Standard Deviation 23.56 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | PedsQL Epilepsy Module-Sleep (Parent Report) | 62.71 score on a scale | Standard Deviation 23.64 |
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.
Time frame: Month 14-17
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Seizure Freedom | 0.69 units on a scale | Standard Deviation 0.47 |
| Treatment Group (E+ADR+IAF) | Seizure Freedom | 0.64 units on a scale | Standard Deviation 0.49 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Seizure Freedom | 0.55 units on a scale | Standard Deviation 0.5 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Seizure Freedom | 0.64 units on a scale | Standard Deviation 0.49 |
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.
Time frame: Months 8-11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Seizure Freedom | 0.54 units on a scale | Standard Deviation 0.5 |
| Treatment Group (E+ADR+IAF) | Seizure Freedom | 0.50 units on a scale | Standard Deviation 0.51 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Seizure Freedom | 0.60 units on a scale | Standard Deviation 0.49 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Seizure Freedom | 0.58 units on a scale | Standard Deviation 0.5 |
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.
Time frame: Month 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Seizure Severity Adapted for Children Scale-Total Score | 0.84 score on a scale | Standard Deviation 0.52 |
| Treatment Group (E+ADR+IAF) | Seizure Severity Adapted for Children Scale-Total Score | 0.87 score on a scale | Standard Deviation 0.5 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Seizure Severity Adapted for Children Scale-Total Score | 0.81 score on a scale | Standard Deviation 0.63 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Seizure Severity Adapted for Children Scale-Total Score | 0.64 score on a scale | Standard Deviation 0.52 |
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.
Time frame: Month 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Seizure Severity Adapted for Children Scale-Total Score | 0.92 score on a scale | Standard Deviation 0.46 |
| Treatment Group (E+ADR+IAF) | Seizure Severity Adapted for Children Scale-Total Score | 0.91 score on a scale | Standard Deviation 0.58 |
| Treatment Group (E+ADR+IAF) non-responsive but continue IAF | Seizure Severity Adapted for Children Scale-Total Score | 0.92 score on a scale | Standard Deviation 0.66 |
| Treatment Group (E+ADR+IAF+PS) non-responsive and PS added | Seizure Severity Adapted for Children Scale-Total Score | 0.86 score on a scale | Standard Deviation 0.6 |