The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.

A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: BreatheSmart System; Other: Standard of Care

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: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Days Covered (PDC)	Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period.	6 months post start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test	The Asthma control Test (ACT) assess a patient's level of asthma control based on responses to 5 symptom-related questions over the past 4 weeks. Respondents must select a number on a 5-point likert scale (1-5) for each item. The response to each question is summed, ranging from 5-25. Scores of 19 or less indicate poorly controlled asthma. Higher scores mean better asthma control.	6 months post start of intervention
FEV1% Predicted	The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months.	Baseline to 6 months
Changes in Medication Adherence and Lung Function	The correlation between changes in medication adherence and changes in FEV1 percent predicted. FEV1 is forced expiratory volume in 1 second is the maximum amount of air that a subject can forcibly expel during the first second following maximal inhalation. FEV1 can be useful to categorize the severity of asthma. Expressing FEV1 as a percentage of the predicted value in a patient is means by which to express this severity.	Baseline to 6 months post start of intervention
Number of Participants With Visits to ER for Asthma	The overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits)	Baseline to 6 months post start of intervention
Number of Missed Days of School	Average number of days missed from school in the past 30 days	Last 30 days from baseline visit and last 30 days from 6-month follow-up visit

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: Tregony Simoneau, MD, Connecticut Childrens Medical Center

Publications and helpful links

General Publications

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
• Hollenbach J, Simoneau T, Sun Y, Becene I, Almeida S, Langton C, Flores G. Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma. Contemp Clin Trials Commun. 2021 Feb 6;21:100706. doi: 10.1016/j.conctc.2021.100706. eCollection 2021 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 17-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NA we are not planning on sharing the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No