Behavioral Economics and Adherence in Teens (BEAT!) (Beat!)

Beat!: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Adherence, Medication
• Intervention / Treatment: Behavioral: Automated Digital Reminders; Behavioral: Individualized Adherence Feedback Report; Behavioral: Individual Adherence Feedback Report with Social Norms

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

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Automated reminders and individualized adherence feedback reports	Behavioral: Automated Digital Reminders; Reminders from electronic monitors via texts or alarms/lights; Behavioral: Individualized Adherence Feedback Report; Feedback report on individual adherence behaviors
Experimental: Treatment Group; Automated reminders and individualized adherence feedback reports with social norms comparisons	Behavioral: Automated Digital Reminders; Reminders from electronic monitors via texts or alarms/lights; Behavioral: Individual Adherence Feedback Report with Social Norms; Feedback report on individual adherence behaviors compared to other adolescents with epilepsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 9
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.	Month 9
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.	Month 9
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.	9-month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 7

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Nursing Research (NINR); Nationwide Children's Hospital

Publications and helpful links

General Publications

• Modi AC, Patel AD, Stevens J, Smith G, Huszti H, Guilfoyle SM, Mara CA, Schmidt M, Wagner JL. The psychosocial impact of COVID-19 within the first six months of the pandemic on youth with epilepsy and their caregivers. Epilepsy Behav. 2021 Apr;117:107855. doi: 10.1016/j.yebeh.2021.107855. Epub 2021 Feb 12.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: adolescents, behavioral economics, mHealth
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2018-8412; R21NR017633 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project will have psychosocial, adherence, demographic, and medical data for children with epilepsy. Deidentified data can be used for many secondary analyses. Prior to sharing, all data will be de-identified in a HIPAA-compliant fashion. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. For example, only year of birth, rather than the full birth date, will be made available. All categorical demographic variables will be collapsed into categories large enough so that combinations of demographic categories for age, gender, geographic location, etc., will have 10 or more individuals in each cell. All modalities of data will be shared, including raw and aggregate data. Descriptors for all variables shared will be included to prevent misuse or confusion. Any analytical methods utilized to assess the data will be defined in shared formats.
• IPD Sharing Time Frame: 12 months following completion of the study
• IPD Sharing Access Criteria: PI will provide the information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No