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Behavioral Economics and Adherence in Teens (BEAT!)
NA trial testing Automated Digital Reminders in Epilepsy in 104 participants. Completed in 16 August 2021.
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 1 September 2019 |
| Primary completion | 31 March 2021 |
| Estimated completion | 16 August 2021 |
| Sites | 1 location across United States |
Children's Hospital Medical Center, Cincinnati
Adults 13 to 17, any sex, with Epilepsy or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 45.5 | ± 32.0 |
| Treatment Group | 50.5 | ± 37.4 |
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
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 2.5 | ± 1.3 |
| Treatment Group | 2.4 | ± 1.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 0.98 | ± 0.55 |
| Treatment Group | 1.11 | ± 0.60 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 83.3 | ± 15.5 |
| Treatment Group | 78.8 | ± 18.0 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 63.1 | ± 28.9 |
| Treatment Group | 72.4 | ± 19.8 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 60.3 | ± 17.1 |
| Treatment Group | 65.1 | ± 22.2 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 71.2 | ± 23.2 |
| Treatment Group | 72.3 | ± 23.9 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 66.5 | ± 18.5 |
| Treatment Group | 67.2 | ± 23.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 80 | ± 13.5 |
| Treatment Group | 82.8 | ± 20.7 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 73.6 | ± 19.9 |
| Treatment Group | 71.6 | ± 26.1 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 56.9 | ± 20.4 |
| Treatment Group | 67.7 | ± 27.2 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 75.7 | ± 13.5 |
| Treatment Group | 65.4 | ± 26.7 |
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 65.4 | ± 15.1 |
| Treatment Group | 71.9 | ± 28.2 |
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 an
| Group | Value | 95% CI |
|---|---|---|
| Control Group | 53.5 | ± 9.0 |
| Treatment Group | 50.8 | ± 6.0 |
Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control Group | Treatment Group |
|---|---|---|---|
| Epilepsy monitoring unit/overnight EEG | Nervous system disorders | — | — |
| Chest pain | Cardiac disorders | — | — |
| Ear tube removal/myringoplasty | Ear and labyrinth disorders | — | — |
| Suicidal Ideation | Psychiatric disorders | — | — |
Data from ClinicalTrials.gov NCT03958331 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03958331.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing