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出境医 / 临床实验 / Behavioral Economics and Adherence in Teens (BEAT!) (Beat!)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Epilepsy Adherence, Medication Behavioral: Automated Digital Reminders Behavioral: Individualized Adherence Feedback Report Behavioral: Individual Adherence Feedback Report with Social Norms Phase 2

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 Design
Layout table for study information
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
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Seizure Severity-Clinician report [ Time Frame: Month 9 ]
    The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of severity, with higher scores representing more severe epilepsy.

  2. Seizure Severity-Parent report [ Time Frame: Month 9 ]
    The Seizure Severity Scale-Adapted for children is a 9-item caregiver report of seizure severity. The total score will be used and higher scores represent worse seizure severity.

  3. Health-related quality of life [ Time Frame: Month 9 ]
    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, with higher scores representing better quality of life.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Nursing Research (NINR)
Nationwide Children's Hospital
Tracking Information
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
 (submitted: May 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Electronically monitored adherence [ Time Frame: Month 7 ]
Mean adherence rates measured via SimpleMed or AdhereTech bottles
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Seizure Severity-Clinician report [ Time Frame: Month 9 ]
    The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of severity, with higher scores representing more severe epilepsy.
  • Seizure Severity-Parent report [ Time Frame: Month 9 ]
    The Seizure Severity Scale-Adapted for children is a 9-item caregiver report of seizure severity. The total score will be used and higher scores represent worse seizure severity.
  • Health-related quality of life [ Time Frame: Month 9 ]
    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, with higher scores representing better quality of life.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Seizure Severity [ Time Frame: Month 9 ]
    Global Assessment of Severity of Epilepsy (GASE)
  • Health-related quality of life [ Time Frame: Month 9 ]
    PedsQL-Epilepsy Module subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior)
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2019)
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.
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
Condition  ICMJE
  • Epilepsy
  • Adherence, Medication
Intervention  ICMJE
  • Behavioral: Automated Digital Reminders
    Reminders from electronic monitors via texts or alarms/lights
  • Behavioral: Individualized Adherence Feedback Report
    Feedback report on individual adherence behaviors
  • Behavioral: Individual Adherence Feedback Report with Social Norms
    Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
Study Arms  ICMJE
  • Active Comparator: Control Group
    Automated reminders and individualized adherence feedback reports
    Interventions:
    • Behavioral: Automated Digital Reminders
    • Behavioral: Individualized Adherence Feedback Report
  • Experimental: Treatment Group
    Automated reminders and individualized adherence feedback reports with social norms comparisons
    Interventions:
    • Behavioral: Automated Digital Reminders
    • Behavioral: Individual Adherence Feedback Report with Social Norms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 13, 2021)
104
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: 12 months following completion of the study
Access Criteria: PI will provide the information
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • Nationwide Children's Hospital
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