Condition or disease | Intervention/treatment | Phase |
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Epilepsy Adherence, Medication | Behavioral: Automated Digital Reminders Behavioral: Individualized Adherence Feedback Report Behavioral: Individual Adherence Feedback Report with Social Norms | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is 2-arm randomized controlled clinical trial to improve adherence in adolescents with epilepsy |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Beat!: A Randomized Controlled Clinical Trial |
Actual Study Start Date : | September 1, 2019 |
Actual Primary Completion Date : | March 31, 2021 |
Estimated Study Completion Date : | July 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Control Group
Automated reminders and individualized adherence feedback reports
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Behavioral: Automated Digital Reminders
Reminders from electronic monitors via texts or alarms/lights
Behavioral: Individualized Adherence Feedback Report Feedback report on individual adherence behaviors
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Experimental: Treatment Group
Automated reminders and individualized adherence feedback reports with social norms comparisons
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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
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Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | May 20, 2019 | ||||||||||||||||
First Posted Date ICMJE | May 22, 2019 | ||||||||||||||||
Last Update Posted Date | May 13, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | September 1, 2019 | ||||||||||||||||
Actual Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Electronically monitored adherence [ Time Frame: Month 7 ] 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.
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Original Primary Outcome Measures ICMJE |
Electronically monitored adherence [ Time Frame: Month 7 ] Mean adherence rates measured via SimpleMed or AdhereTech bottles
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Feasibility and Acceptability-Teen Report [ Time Frame: Month 7 ] 37 item survey regarding satisfaction with content, relevance, helpfulness, ease of use, and likeability. Five open ended questions also assess need for modifications and satisfaction.
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Behavioral Economics and Adherence in Teens (BEAT!) | ||||||||||||||||
Official Title ICMJE | Beat!: A Randomized Controlled Clinical Trial | ||||||||||||||||
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 | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is 2-arm randomized controlled clinical trial to improve adherence in adolescents with epilepsy Masking: Single (Investigator)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Actual Enrollment ICMJE |
104 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
138 | ||||||||||||||||
Estimated Study Completion Date ICMJE | July 1, 2021 | ||||||||||||||||
Actual Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 17 Years (Child) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03958331 | ||||||||||||||||
Other Study ID Numbers ICMJE | 2018-8412 R21NR017633 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||||||||||||||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||||||||||
PRS Account | Children's Hospital Medical Center, Cincinnati | ||||||||||||||||
Verification Date | May 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |