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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

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.


Condition or disease Intervention/treatment Phase
Asthma Device: BreatheSmart System Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Official Title: A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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)
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

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Improvement in asthma control [ Time Frame: Baseline to 6 months post start of intervention ]
    Improves asthma control when compared to control from

  2. Improvement in lung function [ Time Frame: Baseline to 6 months post start of intervention ]
    Improves lung function when compared to control group

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734861


Contacts
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Contact: Tregony Simoneau, MD (860) 545-9440 tsimoneau@connecticutchildrens.org
Contact: Masai McIntosh, BA 860-837-7568 MMcIntosh@connecticutchildrens.org

Locations
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United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Tregony Simoneau, MD    860-545-9440    tsimoneau@connecticutchildrens.org   
Contact: Masai McIntosh, BA    860-837-7568    MMcIntosh@connecticutchildrens.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
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Principal Investigator: Tregony Simoneau, MD Connecticut Childrens Medical Center

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Responsible Party: Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT03734861     History of Changes
Other Study ID Numbers: 17-043
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NA we are not planning on sharing the data

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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

Keywords provided by Connecticut Children's Medical Center:
Asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases