Trial Outcomes & Findings for Epilepsy Adherence in Children and Technology (eACT) (NCT NCT03817229)
NCT ID: NCT03817229
Last Updated: 2025-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
268 participants
Primary outcome timeframe
Stage 1 (Month 5)
Results posted on
2025-10-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
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 \</= 95%) after Stage one and re-randomized to continued 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
|
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 \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Intervention Period-Stage 1
STARTED
|
89
|
179
|
0
|
0
|
|
Intervention Period-Stage 1
COMPLETED
|
83
|
167
|
0
|
0
|
|
Intervention Period-Stage 1
NOT COMPLETED
|
6
|
12
|
0
|
0
|
|
Intervention Period-Stage 2
STARTED
|
83
|
48
|
56
|
63
|
|
Intervention Period-Stage 2
COMPLETED
|
82
|
48
|
55
|
49
|
|
Intervention Period-Stage 2
NOT COMPLETED
|
1
|
0
|
1
|
14
|
|
Post-Intervention
STARTED
|
82
|
48
|
55
|
49
|
|
Post-Intervention
COMPLETED
|
69
|
47
|
49
|
42
|
|
Post-Intervention
NOT COMPLETED
|
13
|
1
|
6
|
7
|
|
Follow-up 1
STARTED
|
69
|
47
|
49
|
42
|
|
Follow-up 1
COMPLETED
|
54
|
36
|
45
|
38
|
|
Follow-up 1
NOT COMPLETED
|
15
|
11
|
4
|
4
|
|
Follow-up 2
STARTED
|
54
|
36
|
45
|
38
|
|
Follow-up 2
COMPLETED
|
45
|
33
|
41
|
33
|
|
Follow-up 2
NOT COMPLETED
|
9
|
3
|
4
|
5
|
Reasons for withdrawal
| Measure |
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
|
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
|
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 \</= 95%) after Stage one and re-randomized to continued 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
|
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 \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
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 1
Weaned from medication
|
0
|
3
|
0
|
0
|
|
Intervention Period-Stage 2
Withdrawal by Subject
|
1
|
0
|
1
|
10
|
|
Intervention Period-Stage 2
Withdrawal by Study Team
|
0
|
0
|
0
|
3
|
|
Intervention Period-Stage 2
Weaned from medication
|
0
|
0
|
0
|
1
|
|
Post-Intervention
Withdrawal by Subject
|
6
|
0
|
2
|
2
|
|
Post-Intervention
Withdrawal by Study Team
|
3
|
1
|
1
|
4
|
|
Post-Intervention
Weaned from medication
|
3
|
0
|
2
|
1
|
|
Post-Intervention
Transferred care to another institution
|
1
|
0
|
0
|
0
|
|
Post-Intervention
Change in parental guardianship
|
0
|
0
|
1
|
0
|
|
Follow-up 1
Ineligible for this follow-up visit due to study timing
|
7
|
4
|
4
|
3
|
|
Follow-up 1
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Follow-up 1
Withdrawal by Study Team
|
3
|
1
|
0
|
0
|
|
Follow-up 1
Wean from medication
|
3
|
4
|
0
|
1
|
|
Follow-up 1
Transferred care to another hospital
|
1
|
0
|
0
|
0
|
|
Follow-up 2
Ineligible for this follow-up visit due to study timing
|
4
|
3
|
1
|
4
|
|
Follow-up 2
Withdrawal by Subject
|
2
|
0
|
1
|
1
|
|
Follow-up 2
Withdrawal by Study Team
|
2
|
0
|
1
|
0
|
|
Follow-up 2
Wean from medication
|
1
|
0
|
0
|
0
|
|
Follow-up 2
Transferred care
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Epilepsy Adherence in Children and Technology (eACT)
Baseline characteristics by cohort
| Measure |
Control Group
n=89 Participants
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
|
Treatment Group
n=179 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). 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
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.4 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
7.4 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
179 participants
n=7 Participants
|
268 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=83 Participants
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
|
Treatment Group (E+ADR+IAF)
n=167 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
|
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 \</= 95%) after Stage one and re-randomized to continued 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
|
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 \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Anti-seizure Medication Adherence Rate
|
68.93 score on a scale
Standard Deviation 35.65
|
77.23 score on a scale
Standard Deviation 27.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 8lectronically 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.
Outcome measures
| Measure |
Control Group
n=70 Participants
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
|
Treatment Group (E+ADR+IAF)
n=47 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=51 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=43 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Antiseizure Medication Adherence Rate
|
58.80 score on a scale
Standard Deviation 32.29
|
74.42 score on a scale
Standard Deviation 32.02
|
48.87 score on a scale
Standard Deviation 33.27
|
54.76 score on a scale
Standard Deviation 34.98
|
SECONDARY outcome
Timeframe: Month 7 (Stage 2)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.
Outcome measures
| Measure |
Control Group
n=73 Participants
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
|
Treatment Group (E+ADR+IAF)
n=48 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=54 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=46 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Antiseizure Medication Adherence Rate
|
71.68 score on a scale
Standard Deviation 31.99
|
91.66 score on a scale
Standard Deviation 14.98
|
68.52 score on a scale
Standard Deviation 25.93
|
79.71 score on a scale
Standard Deviation 23.05
|
SECONDARY outcome
Timeframe: Months 8-13The 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.
Outcome measures
| Measure |
Control Group
n=75 Participants
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
|
Treatment Group (E+ADR+IAF)
n=44 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=52 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=46 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Global Assessment of Severity of Epilepsy
|
0.28 units on a scale
Standard Deviation 0.45
|
0.25 units on a scale
Standard Deviation 0.44
|
0.33 units on a scale
Standard Deviation 0.47
|
0.24 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Month 8The 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.
Outcome measures
| Measure |
Control Group
n=65 Participants
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
|
Treatment Group (E+ADR+IAF)
n=45 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Impact (Parent Report)
|
78.76 score on a scale
Standard Deviation 18.25
|
81.67 score on a scale
Standard Deviation 18.52
|
81.01 score on a scale
Standard Deviation 21.57
|
85.07 score on a scale
Standard Deviation 16.52
|
SECONDARY outcome
Timeframe: Month 8Seizure 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.
Outcome measures
| Measure |
Control Group
n=66 Participants
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
|
Treatment Group (E+ADR+IAF)
n=44 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=42 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=41 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Seizure Severity Adapted for Children Scale-Total Score
|
0.92 score on a scale
Standard Deviation 0.46
|
0.91 score on a scale
Standard Deviation 0.58
|
0.92 score on a scale
Standard Deviation 0.66
|
0.86 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Months 8-11Seizure 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.
Outcome measures
| Measure |
Control Group
n=71 Participants
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
|
Treatment Group (E+ADR+IAF)
n=48 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=50 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=48 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Seizure Freedom
|
0.54 units on a scale
Standard Deviation 0.50
|
0.50 units on a scale
Standard Deviation 0.51
|
0.60 units on a scale
Standard Deviation 0.49
|
0.58 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Month 14lectronically 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.
Outcome measures
| Measure |
Control Group
n=44 Participants
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
|
Treatment Group (E+ADR+IAF)
n=35 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=33 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=27 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Antiseizure Medication Adherence Rate
|
50.26 score on a scale
Standard Deviation 33.46
|
72.76 score on a scale
Standard Deviation 36.16
|
43.26 score on a scale
Standard Deviation 31.72
|
59.02 score on a scale
Standard Deviation 31.00
|
SECONDARY outcome
Timeframe: Months 14-19The 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.
Outcome measures
| Measure |
Control Group
n=53 Participants
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
|
Treatment Group (E+ADR+IAF)
n=33 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Global Assessment of Severity of Epilepsy
|
0.19 units on a scale
Standard Deviation 0.39
|
0.18 units on a scale
Standard Deviation 0.39
|
0.35 units on a scale
Standard Deviation 0.48
|
0.35 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Month 14The 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.
Outcome measures
| Measure |
Control Group
n=34 Participants
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
|
Treatment Group (E+ADR+IAF)
n=29 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=30 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Impact (Parent Report)
|
82.2 score on a scale
Standard Deviation 16.64
|
82.14 score on a scale
Standard Deviation 19.76
|
82.03 score on a scale
Standard Deviation 21.82
|
85.19 score on a scale
Standard Deviation 14.11
|
SECONDARY outcome
Timeframe: Month 8The 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.
Outcome measures
| Measure |
Control Group
n=65 Participants
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
|
Treatment Group (E+ADR+IAF)
n=45 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Cognition (Parent Report)
|
62.15 score on a scale
Standard Deviation 27.43
|
68.89 score on a scale
Standard Deviation 27.74
|
63.56 score on a scale
Standard Deviation 28.51
|
64.35 score on a scale
Standard Deviation 29.68
|
SECONDARY outcome
Timeframe: Month 14The 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.
Outcome measures
| Measure |
Control Group
n=34 Participants
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
|
Treatment Group (E+ADR+IAF)
n=29 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=30 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Cognition (Parent Report)
|
61.90 score on a scale
Standard Deviation 27.11
|
69.20 score on a scale
Standard Deviation 25.97
|
63.85 score on a scale
Standard Deviation 26.66
|
65.03 score on a scale
Standard Deviation 30.09
|
SECONDARY outcome
Timeframe: Month 8The 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.
Outcome measures
| Measure |
Control Group
n=65 Participants
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
|
Treatment Group (E+ADR+IAF)
n=45 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Sleep (Parent Report)
|
51.92 score on a scale
Standard Deviation 25.74
|
59.07 score on a scale
Standard Deviation 23.78
|
59.27 score on a scale
Standard Deviation 23.56
|
62.71 score on a scale
Standard Deviation 23.64
|
SECONDARY outcome
Timeframe: Month 14The 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.
Outcome measures
| Measure |
Control Group
n=34 Participants
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
|
Treatment Group (E+ADR+IAF)
n=29 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=30 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Sleep (Parent Report)
|
54.53 score on a scale
Standard Deviation 23.44
|
57.76 score on a scale
Standard Deviation 27.09
|
62.01 score on a scale
Standard Deviation 22.49
|
61.53 score on a scale
Standard Deviation 27.28
|
SECONDARY outcome
Timeframe: Month 8The 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.
Outcome measures
| Measure |
Control Group
n=65 Participants
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
|
Treatment Group (E+ADR+IAF)
n=45 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
|
51.70 score on a scale
Standard Deviation 28.51
|
63.80 score on a scale
Standard Deviation 24.43
|
56.46 score on a scale
Standard Deviation 30.40
|
59.43 score on a scale
Standard Deviation 28.58
|
SECONDARY outcome
Timeframe: Month 14The 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.
Outcome measures
| Measure |
Control Group
n=34 Participants
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
|
Treatment Group (E+ADR+IAF)
n=29 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=30 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Executive Functioning (Parent Report)
|
55.27 score on a scale
Standard Deviation 32.87
|
59.05 score on a scale
Standard Deviation 27.56
|
58.54 score on a scale
Standard Deviation 27.98
|
57.71 score on a scale
Standard Deviation 29.69
|
SECONDARY outcome
Timeframe: Month 14The 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.
Outcome measures
| Measure |
Control Group
n=34 Participants
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
|
Treatment Group (E+ADR+IAF)
n=29 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=34 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=30 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
|
61.91 score on a scale
Standard Deviation 20.67
|
70.00 score on a scale
Standard Deviation 18.37
|
64.56 score on a scale
Standard Deviation 19.12
|
68.50 score on a scale
Standard Deviation 24.88
|
SECONDARY outcome
Timeframe: Month 8The 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.
Outcome measures
| Measure |
Control Group
n=65 Participants
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
|
Treatment Group (E+ADR+IAF)
n=45 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
PedsQL Epilepsy Module-Mood/Behavior (Parent Report)
|
63.08 score on a scale
Standard Deviation 21.61
|
74.44 score on a scale
Standard Deviation 17.56
|
69.62 score on a scale
Standard Deviation 19.13
|
69.12 score on a scale
Standard Deviation 22.64
|
SECONDARY outcome
Timeframe: Month 14-17Seizure 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.
Outcome measures
| Measure |
Control Group
n=48 Participants
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
|
Treatment Group (E+ADR+IAF)
n=39 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=40 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=36 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Seizure Freedom
|
0.69 units on a scale
Standard Deviation 0.47
|
0.64 units on a scale
Standard Deviation 0.49
|
0.55 units on a scale
Standard Deviation 0.50
|
0.64 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Month 14Seizure 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.
Outcome measures
| Measure |
Control Group
n=35 Participants
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
|
Treatment Group (E+ADR+IAF)
n=31 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=35 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=29 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Seizure Severity Adapted for Children Scale-Total Score
|
0.84 score on a scale
Standard Deviation 0.52
|
0.87 score on a scale
Standard Deviation 0.50
|
0.81 score on a scale
Standard Deviation 0.63
|
0.64 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Months 8-14Emergency 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.
Outcome measures
| Measure |
Control Group
n=55 Participants
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
|
Treatment Group (E+ADR+IAF)
n=41 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=43 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=37 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Emergency Room and Urgent Care Visits Combined
|
0.33 number of emergency room visits
Standard Deviation 0.84
|
0.12 number of emergency room visits
Standard Deviation 0.40
|
0.28 number of emergency room visits
Standard Deviation 0.55
|
0.32 number of emergency room visits
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Months 8-14Number of inpatient hospitalization based on medical chart review and caregiver report. Higher numbers mean a higher level of inpatient hospitalizations.
Outcome measures
| Measure |
Control Group
n=55 Participants
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
|
Treatment Group (E+ADR+IAF)
n=41 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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=43 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=37 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). These participants were considered non-responsive (adherence \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Hospitalizations (Healthcare Utilization)
|
0.13 number of inpatient hospitalizations
Standard Deviation 0.47
|
0.17 number of inpatient hospitalizations
Standard Deviation 0.38
|
0.30 number of inpatient hospitalizations
Standard Deviation 0.47
|
0.32 number of inpatient hospitalizations
Standard Deviation 0.63
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Treatment Group (E+ADR+IAF in Stage 1 and remained in Stage 2)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=89 participants at risk
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
|
Treatment Group (E+ADR+IAF in Stage 1 and remained in Stage 2)
n=48 participants at risk
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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=56 participants at risk
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 \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=63 participants at risk
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 \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/89 • 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.
|
0.00%
0/48 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
0.00%
0/63 • 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.
|
Other adverse events
| Measure |
Control Group
n=89 participants at risk
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
|
Treatment Group (E+ADR+IAF in Stage 1 and remained in Stage 2)
n=48 participants at risk
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
|
Treatment Group (E+ADR+IAF) non-responsive but continue IAF
n=56 participants at risk
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 \</= 95%) after Stage one and re-randomized to continued 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
|
Treatment Group (E+ADR+IAF+PS) non-responsive and PS added
n=63 participants at risk
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 \</= 95%) after Stage one and re-randomized to two additional problem-solving sessions with a telehealth therapist.
Education microlearning sessions: mHealth education microlearning sessions
Automated digital reminders: reminders from electronic monitors based on texts or lights/chimes
Problem-solving sessions with a therapist via telehealth: Two sessions over two months.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Cardiac disorders
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
1.6%
1/63 • Number of events 1 • 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.
|
|
Ear and labyrinth disorders
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Gastrointestinal disorders
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
0.00%
0/48 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
0.00%
0/63 • 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.
|
|
General disorders
Medical complications not related to epilepsy
|
2.2%
2/89 • Number of events 6 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Hepatobiliary disorders
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
0.00%
0/48 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
0.00%
0/63 • 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.
|
|
Immune system disorders
Medical complications not related to epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Infections and infestations
Medical complications not related to epilepsy
|
14.6%
13/89 • Number of events 18 • 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.
|
6.2%
3/48 • Number of events 3 • 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.
|
10.7%
6/56 • Number of events 8 • 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.
|
11.1%
7/63 • Number of events 19 • 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.
|
|
Injury, poisoning and procedural complications
Medical complications not related to epilepsy
|
7.9%
7/89 • Number of events 8 • 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.
|
0.00%
0/48 • 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.
|
8.9%
5/56 • Number of events 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.
|
4.8%
3/63 • Number of events 3 • 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.
|
|
Product Issues
Medical complications not related to epilepsy
|
0.00%
0/89 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
1.6%
1/63 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Medical complications not related to epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Medical complications not related to epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
0.00%
0/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Medical complications not related to epilepsy
|
3.4%
3/89 • Number of events 7 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Surgical and medical procedures
Medical complications not related to epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
0.00%
0/56 • 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.
|
0.00%
0/63 • 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.
|
|
Investigations
Planned Inpatient/Outpatient Procedures Not Related to Epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
1.6%
1/63 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Planned Inpatient/Outpatient Procedures Not Related to Epilepsy
|
1.1%
1/89 • Number of events 1 • 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.
|
4.2%
2/48 • Number of events 2 • 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.
|
12.5%
7/56 • Number of events 7 • 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.
|
3.2%
2/63 • Number of events 2 • 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.
|
|
Nervous system disorders
Medical complications related to epilepsy
|
10.1%
9/89 • Number of events 24 • 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.
|
4.2%
2/48 • Number of events 3 • 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.
|
10.7%
6/56 • Number of events 6 • 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.
|
11.1%
7/63 • Number of events 9 • 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.
|
|
Surgical and medical procedures
Planned Inpatient/Outpatient Procedures Related to Epilepsy
|
5.6%
5/89 • Number of events 7 • 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.
|
6.2%
3/48 • Number of events 4 • 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.
|
14.3%
8/56 • Number of events 10 • 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.
|
6.3%
4/63 • Number of events 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.
|
|
Psychiatric disorders
Psychological Complications
|
3.4%
3/89 • Number of events 3 • 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.
|
4.2%
2/48 • Number of events 2 • 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.
|
1.8%
1/56 • Number of events 1 • 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.
|
1.6%
1/63 • Number of events 1 • 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.
|
Additional Information
Avani Modi, Ph.D.
Cincinnati Children's Hospital Medical Center
Phone: 5136364864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place