Behavioral Economics and Adherence in Teens (BEAT!)
Beat!
Beat!: A Randomized Controlled Clinical Trial
2 other identifiers
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2021
CompletedResults Posted
Study results publicly available
September 23, 2022
CompletedSeptember 23, 2022
September 1, 2022
1.6 years
May 20, 2019
July 12, 2022
September 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Seizure Severity-Clinician Report
Month 9
Seizure Severity-Parent Report
Month 9
PedsQL Epilepsy Module - Parent Report
Month 9
PedsQL Epilepsy Module-Adolescent Report
9-month
Other Outcomes (1)
Satisfaction-Teen Report Total Score
Month 7
Study Arms (2)
Control Group
ACTIVE COMPARATORAutomated reminders and individualized adherence feedback reports
Treatment Group
EXPERIMENTALAutomated reminders and individualized adherence feedback reports with social norms comparisons
Interventions
Reminders from electronic monitors via texts or alarms/lights
Feedback report on individual adherence behaviors
Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
Eligibility Criteria
You may qualify if:
- Ages 13-17
- Confirmed diagnosis of epilepsy
- Antiepileptic drug monotherapy
- Ability to read and speak English
You may not qualify if:
- No significant developmental delay (e.g., autism, moderate/severe developmental or intellectual disability) or comorbid medical diagnoses (e.g., diabetes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
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.
PMID: 33636530RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to COVID-19, we recruited less participants than originally anticipated for the trial (n=104 versus n=138).
Results Point of Contact
- Title
- Dr. Avani Modi
- Organization
- Cincinnati Children's Hospital Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 22, 2019
Study Start
September 1, 2019
Primary Completion
March 31, 2021
Study Completion
August 16, 2021
Last Updated
September 23, 2022
Results First Posted
September 23, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- 12 months following completion of the study
- Access Criteria
- PI will provide the information
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.