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The Study is Enrolling Kids From 7 to 16 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.

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ClinicalTrials.gov Identifier: NCT03734861
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Connecticut Children's Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Relative improvement in medication adherence [ Time Frame: Baseline to 6 months post start of intervention ]
Estimating the relative improvement in medication adherence among children using BreatheSmart with feedback compared to control at 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Improvement in asthma control [ Time Frame: Baseline to 6 months post start of intervention ]
    Improves asthma control when compared to control from
  • Improvement in lung function [ Time Frame: Baseline to 6 months post start of intervention ]
    Improves lung function when compared to control group
  • Changes in medication adherence and lung function [ Time Frame: Baseline to 6 months post start of intervention ]
    The correlation between changes in medication adherence and changes in FEV1 and FEV1/FVC ratio
  • Reduction in visit for asthma related adverse events [ Time Frame: Baseline to 6 months post start of intervention ]
    Reduces the overall number of provider visits for asthma related adverse events
  • Decrease in the number of missed days of school [ Time Frame: Baseline to 6 months post start of intervention ]
    Reduces the number of missed school days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study is Enrolling Kids From 7 to 16 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Official Title  ICMJE A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
Brief Summary

Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change.

This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.

Detailed Description

This is a prospective, randomized, controlled study of children with persistent asthma who are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into one of two arms:

  • 50 children will be randomized to BreatheSmart, comprised of:

    • BreatheSmart mobile application that tracks medication usage and sends real time reminders
    • HeroTracker sensor that counts dosage and monitors real-time medication adherence
    • CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)
  • 25 children will be randomized to "standard of care"(control arm). These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomized to one of two arms:

  1. BreathSmart system
  2. Standard of Care
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Asthma
Intervention  ICMJE
  • Device: BreatheSmart System
    • BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders
    • HeroTracker sensor that counts dosage and monitors real-time medication adherence
    • CoheroConnect provider portal that allows the Investigator to monitor adherence
  • Other: Standard of Care
    These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Study Arms  ICMJE
  • Experimental: BreatheSmart System
    • BreatheSmart mobile application that tracks medication usage and sends real time reminders
    • HeroTracker sensor that counts dosage and monitors real-time medication adherence
    • CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)
    Intervention: Device: BreatheSmart System
  • Active Comparator: Standard of Care
    These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
    Intervention: Other: Standard of Care
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 8 to 17
  • Diagnosis of persistent asthma
  • Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment
  • Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix)
  • Parent/child possess a compatible smartphone (iOS 8.0 or higher)
  • English or Spanish speaking

Exclusion Criteria:

  • Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy
  • Presence of other chronic medical condition such as congenital heart disease or immunodeficiency
  • Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to < 1 year
  • Currently pregnant or planning to become pregnant during the trial period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tregony Simoneau, MD (860) 545-9440 tsimoneau@connecticutchildrens.org
Contact: Masai McIntosh, BA 860-837-7568 MMcIntosh@connecticutchildrens.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03734861
Other Study ID Numbers  ICMJE 17-043
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: NA we are not planning on sharing the data
Responsible Party Connecticut Children's Medical Center
Study Sponsor  ICMJE Connecticut Children's Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tregony Simoneau, MD Connecticut Childrens Medical Center
PRS Account Connecticut Children's Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP