Beat!: A Randomized Controlled Clinical Trial

Behavioral Economics and Adherence in Teens (BEAT!)

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: National Institute of Nursing Research (NINR)
Nationwide Children's Hospital

Source Children's Hospital Medical Center, Cincinnati
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 will address these aims through an iterative process, including an adolescent focus group (ORBIT Phase 1a: Define; n=8), extended usage test (ORBIT Phase 1b: Refine; n=10) and a pilot RCT of the final mHealth social norms intervention (ORBIT Phase II: Pilot; n=138). 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

Overall Status Recruiting
Start Date September 1, 2019
Completion Date November 1, 2020
Primary Completion Date August 1, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Electronically monitored adherence Month 7
Secondary Outcome
Measure Time Frame
Seizure Severity-Clinician report Month 9
Seizure Severity-Parent report Month 9
Health-related quality of life Month 9
Enrollment 138
Condition
Intervention

Intervention type: Behavioral

Intervention name: Automated Digital Reminders

Description: Reminders from electronic monitors via texts or alarms/lights

Intervention type: Behavioral

Intervention name: Individualized Adherence Feedback Report

Description: Feedback report on individual adherence behaviors

Arm group label: Control Group

Intervention type: Behavioral

Intervention name: Individual Adherence Feedback Report with Social Norms

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

Arm group label: Treatment Group

Eligibility

Criteria:

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)

Gender: All

Minimum age: 13 Years

Maximum age: 17 Years

Healthy volunteers: No

Overall Contact

Last name: Avani Modi, Ph.D.

Phone: 513-636-4864

Email: [email protected]

Location
facility status contact
Nationwide Children's Hospital Recruiting Jack Stevens, Ph.D. 614-722-3182 [email protected]
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control Group

Arm group type: Active Comparator

Description: Automated reminders and individualized adherence feedback reports

Arm group label: Treatment Group

Arm group type: Experimental

Description: Automated reminders and individualized adherence feedback reports with social norms comparisons

Acronym Beat!
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov