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Behavioral Economics and Adherence in Teens (BEAT!)

Beat!: A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03958331
Acronym
Beat!
Enrollment
104
Registered
2019-05-22
Start date
2019-09-01
Completion date
2021-08-16
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Medication, Epilepsy

Keywords

adolescents, behavioral economics, mHealth

Brief summary

Non-adherence to antiepileptic drug therapy is a significant problem for adolescents with epilepsy and has a critical impact on health and patient-reported outcomes. Evidence-based adherence interventions are lacking in this population and are critically needed. This proposal seeks to develop and evaluate a mHealth social norms adherence intervention for adolescents with epilepsy.

Detailed description

Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for youth with epilepsy, with potentially devastating consequences. Adolescents with epilepsy represent a particularly vulnerable group, given their increased independence, decreased parental supervision, higher risk for deficits in organization and memory, busy and changing schedules, low motivation, and increased susceptibility to peer influence. Existing adherence interventions in epilepsy are not designed to meet the unique challenges faced by adolescents, and there are no efficacious interventions for adolescents with epilepsy. Not surprisingly, without efficacious interventions, adherence worsens during adolescence, further increasing the risk of poor health outcomes during this developmental period. While reminder strategies (e.g., automated digital reminders) are effective for the most common adherence barriers of forgetting and busy schedules, they are likely to be ineffective in increasing motivation. Leveraging social norms comparison methods (i.e., feedback about someone else's behavior related to one's own behavior) offers an opportunity to capitalize on the increased importance of peer influence while simultaneously targeting the low motivation characteristic of adolescents. Recent data in adolescents indicates that social norms interventions have incremental value and improve health behaviors above and beyond standard feedback without peer comparisons. Consistent with the ORBIT model for behavioral intervention development, our aims are to: 1) develop a feasible, accessible, and acceptable mHealth social norms intervention for improving AED adherence in adolescents with epilepsy and 2) obtain preliminary efficacy data and effect sizes for a future clinical trial. We conducted a pilot RCT of an mHealth social norms intervention (ORBIT Phase II). Adolescents with epilepsy who demonstrate non-adherence (\< 95% adherence based on PI's previous RCTs; 58% of sample) during baseline will be randomized to either 1) mHealth social norms (automated digital reminders, individualized adherence feedback, and social norms feedback) or 2) control (automated digital reminders and individualized adherence feedback). Both groups will receive active intervention for five months. Primary (i.e., electronically-monitored adherence) and secondary outcomes (i.e., seizure severity, HRQOL) will be assessed post-treatment and 3 months later, respectively. If successful, the results of this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence by reducing common barriers to behavioral health care. Because minimal clinician time is required, our mHealth social norms intervention also has potential for sustainability and broad dissemination for epilepsy and other pediatric conditions

Interventions

Reminders from electronic monitors via texts or alarms/lights

Feedback report on individual adherence behaviors

BEHAVIORALIndividual Adherence Feedback Report with Social Norms

Feedback report on individual adherence behaviors compared to other adolescents with epilepsy

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Nationwide Children's Hospital
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

This is 2-arm randomized controlled clinical trial to improve adherence in adolescents with epilepsy

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Ages 13-17 * Confirmed diagnosis of epilepsy * Antiepileptic drug monotherapy * Ability to read and speak English

Exclusion criteria

* No significant developmental delay (e.g., autism, moderate/severe developmental or intellectual disability) or comorbid medical diagnoses (e.g., diabetes)

Design outcomes

Primary

MeasureTime frameDescription
Electronically Monitored AdherenceMonth 7A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence.

Secondary

MeasureTime frameDescription
Seizure Severity-Clinician ReportMonth 9The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of seizure severity. The total score ranges from 1-7, with higher scores representing more severe epilepsy
Seizure Severity-Parent ReportMonth 9The Seizure Severity Scale-Adapted for Children is a caregiver-reported questionnaire, which is 9-items and assess seizure severity, including intrusiveness, frequency, length, and disruptiveness of seizures. A total score is calculated, ranging from 0-3, with higher scores representing worse seizure severity.
PedsQL Epilepsy Module - Parent ReportMonth 9The PedsQL-Epilepsy Module is a 29 item measure with several subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior) will be used. Scores range from 0-100 for each subscale, with higher scores representing better quality of life.
PedsQL Epilepsy Module-Adolescent Report9-monthThe PedsQL Epilepsy Module is a 29-item health-related quality of life instrument with five subscales, including Impact, Cognitive, Executive Functioning, Sleep, and Mood/Behavior). Scores range from 0-100, with higher scores representing better quality of life.

Other

MeasureTime frameDescription
Satisfaction-Teen Report Total ScoreMonth 7Adolescents completed this study specific Satisfaction measure, which was 23-items. This measure assesses satisfaction with the intervention content, relevance, helpfulness, and ease of use. Assessment of perceptions of the impact of what was learned from the intervention were also assessed. Eighteen of the items used a Likert format with the following ratings: Strongly Disagree, Disagree, Agree, and Strongly Agree. A total scale was calculated for the 18 items, which ranges from 18-72, with higher scores reflecting higher satisfaction. Finally, five open-ended items assessing what was most and least helpful about the intervention, what changes adolescents want to see in the intervention, and any additional input.

Countries

United States

Participant flow

Pre-assignment details

We had a run-in period, in which 64 participants were not randomized to either control or treatment groups. The primary participants in this study were adolescents and caregivers did not receive the intervention. Caregivers completed parental permission (consent) forms, demographic information related to their child and provided data for two of the secondary outcomes.

Participants by arm

ArmCount
Control Group
Automated reminders and individualized adherence feedback reports Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
21
Treatment Group
Automated reminders and individualized adherence feedback reports with social norms comparisons Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
19
Not Randomized
No interventions were provided to these participants as they demonstrated high adherence and were not eligible for randomization based on the run-in period.
64
Total104

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWeaned from medicine200
Overall StudyWithdrawal by Subject315
Overall StudyWithdrawn by study staff due to non-compliance with study procedures2112

Baseline characteristics

CharacteristicControl GroupTreatment GroupNot RandomizedTotal
Age, Continuous15.2 years
STANDARD_DEVIATION 1.2
14.9 years
STANDARD_DEVIATION 3.2
15.6 years
STANDARD_DEVIATION 1.4
15.4 years
STANDARD_DEVIATION 1.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants18 Participants62 Participants101 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants1 Participants
Family Insurance
Not insured
0 Participants0 Participants2 Participants2 Participants
Family Insurance
Private
10 Participants17 Participants43 Participants70 Participants
Family Insurance
Public
9 Participants2 Participants18 Participants29 Participants
Family Insurance
Public and Private
2 Participants0 Participants1 Participants3 Participants
Monotherapy versus Polytherapy
Monotherapy
21 Participants17 Participants61 Participants99 Participants
Monotherapy versus Polytherapy
Polytherapy
0 Participants2 Participants2 Participants4 Participants
Monotherapy versus Polytherapy
Unknown
0 Participants0 Participants1 Participants1 Participants
Primary Caregiver
Father/Stepfather
4 Participants3 Participants2 Participants9 Participants
Primary Caregiver
Mother/Stepmother
16 Participants16 Participants51 Participants83 Participants
Primary Caregiver
Other: Grandmother, Uncle, Aunt
1 Participants0 Participants0 Participants1 Participants
Primary Caregiver
Unknown
0 Participants0 Participants11 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants1 Participants5 Participants
Race (NIH/OMB)
More than one race
5 Participants3 Participants4 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
13 Participants15 Participants58 Participants86 Participants
Seizures in the Past 3 months
No
13 Participants13 Participants39 Participants65 Participants
Seizures in the Past 3 months
Unknown
0 Participants0 Participants11 Participants11 Participants
Seizures in the Past 3 months
Yes
8 Participants6 Participants14 Participants28 Participants
Seizure Type
Focal
5 Participants7 Participants9 Participants21 Participants
Seizure Type
Generalized
14 Participants9 Participants46 Participants69 Participants
Seizure Type
Unclassified
2 Participants3 Participants8 Participants13 Participants
Seizure Type
Unknown
0 Participants0 Participants1 Participants1 Participants
Sex: Female, Male
Female
8 Participants9 Participants38 Participants55 Participants
Sex: Female, Male
Male
13 Participants10 Participants26 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 19
other
Total, other adverse events
3 / 216 / 19
serious
Total, serious adverse events
0 / 210 / 19

Outcome results

Primary

Electronically Monitored Adherence

A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence.

Time frame: Month 7

Population: Adherence data missing for 2 participants

ArmMeasureValue (MEAN)Dispersion
Control GroupElectronically Monitored Adherence45.5 units on a scaleStandard Deviation 32
Treatment GroupElectronically Monitored Adherence50.5 units on a scaleStandard Deviation 37.4
p-value: 0.00295% CI: [4, 17.25]ANCOVA
Secondary

PedsQL Epilepsy Module-Adolescent Report

The PedsQL Epilepsy Module is a 29-item health-related quality of life instrument with five subscales, including Impact, Cognitive, Executive Functioning, Sleep, and Mood/Behavior). Scores range from 0-100, with higher scores representing better quality of life.

Time frame: 9-month

Population: The flow diagram differs in sample size as one less adolescent completed this measure. Thus, the sample size is n=12.

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupPedsQL Epilepsy Module-Adolescent ReportCognitive73.6 score on a scaleStandard Deviation 19.9
Control GroupPedsQL Epilepsy Module-Adolescent ReportExecutive Functioning75.7 score on a scaleStandard Deviation 13.5
Control GroupPedsQL Epilepsy Module-Adolescent ReportSleep56.9 score on a scaleStandard Deviation 20.4
Control GroupPedsQL Epilepsy Module-Adolescent ReportMood/Behavior65.4 score on a scaleStandard Deviation 15.1
Control GroupPedsQL Epilepsy Module-Adolescent ReportImpact80 score on a scaleStandard Deviation 13.5
Treatment GroupPedsQL Epilepsy Module-Adolescent ReportMood/Behavior71.9 score on a scaleStandard Deviation 28.2
Treatment GroupPedsQL Epilepsy Module-Adolescent ReportImpact82.8 score on a scaleStandard Deviation 20.7
Treatment GroupPedsQL Epilepsy Module-Adolescent ReportCognitive71.6 score on a scaleStandard Deviation 26.1
Treatment GroupPedsQL Epilepsy Module-Adolescent ReportSleep67.7 score on a scaleStandard Deviation 27.2
Treatment GroupPedsQL Epilepsy Module-Adolescent ReportExecutive Functioning65.4 score on a scaleStandard Deviation 26.7
Secondary

PedsQL Epilepsy Module - Parent Report

The PedsQL-Epilepsy Module is a 29 item measure with several subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior) will be used. Scores range from 0-100 for each subscale, with higher scores representing better quality of life.

Time frame: Month 9

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupPedsQL Epilepsy Module - Parent ReportCognitive (parent)63.1 score on a scaleStandard Deviation 28.9
Control GroupPedsQL Epilepsy Module - Parent ReportExecutive functioning (parent)71.2 score on a scaleStandard Deviation 23.2
Control GroupPedsQL Epilepsy Module - Parent ReportSleep (parent)60.3 score on a scaleStandard Deviation 17.1
Control GroupPedsQL Epilepsy Module - Parent ReportMood/Behavior (parent)66.5 score on a scaleStandard Deviation 18.5
Control GroupPedsQL Epilepsy Module - Parent ReportImpact (parent)83.3 score on a scaleStandard Deviation 15.5
Treatment GroupPedsQL Epilepsy Module - Parent ReportMood/Behavior (parent)67.2 score on a scaleStandard Deviation 23.2
Treatment GroupPedsQL Epilepsy Module - Parent ReportImpact (parent)78.8 score on a scaleStandard Deviation 18
Treatment GroupPedsQL Epilepsy Module - Parent ReportCognitive (parent)72.4 score on a scaleStandard Deviation 19.8
Treatment GroupPedsQL Epilepsy Module - Parent ReportSleep (parent)65.1 score on a scaleStandard Deviation 22.2
Treatment GroupPedsQL Epilepsy Module - Parent ReportExecutive functioning (parent)72.3 score on a scaleStandard Deviation 23.9
Secondary

Seizure Severity-Clinician Report

The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of seizure severity. The total score ranges from 1-7, with higher scores representing more severe epilepsy

Time frame: Month 9

ArmMeasureValue (MEAN)Dispersion
Control GroupSeizure Severity-Clinician Report2.5 score on a scaleStandard Deviation 1.3
Treatment GroupSeizure Severity-Clinician Report2.4 score on a scaleStandard Deviation 1.2
Secondary

Seizure Severity-Parent Report

The Seizure Severity Scale-Adapted for Children is a caregiver-reported questionnaire, which is 9-items and assess seizure severity, including intrusiveness, frequency, length, and disruptiveness of seizures. A total score is calculated, ranging from 0-3, with higher scores representing worse seizure severity.

Time frame: Month 9

Population: The number of participants analyzed does not match the participant flow as some participants did not complete this particular measure.

ArmMeasureValue (MEAN)Dispersion
Control GroupSeizure Severity-Parent Report0.98 score on a scaleStandard Deviation 0.55
Treatment GroupSeizure Severity-Parent Report1.11 score on a scaleStandard Deviation 0.6
Other Pre-specified

Satisfaction-Teen Report Total Score

Adolescents completed this study specific Satisfaction measure, which was 23-items. This measure assesses satisfaction with the intervention content, relevance, helpfulness, and ease of use. Assessment of perceptions of the impact of what was learned from the intervention were also assessed. Eighteen of the items used a Likert format with the following ratings: Strongly Disagree, Disagree, Agree, and Strongly Agree. A total scale was calculated for the 18 items, which ranges from 18-72, with higher scores reflecting higher satisfaction. Finally, five open-ended items assessing what was most and least helpful about the intervention, what changes adolescents want to see in the intervention, and any additional input.

Time frame: Month 7

Population: Participant numbers are lower than the Participant Flow data as some participants did not complete this particular measure.

ArmMeasureValue (MEAN)Dispersion
Control GroupSatisfaction-Teen Report Total Score53.5 score on a scaleStandard Deviation 9
Treatment GroupSatisfaction-Teen Report Total Score50.8 score on a scaleStandard Deviation 6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026