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

NCT03734861 | Completed Results FDA Device

• 1 other identifier: 17-043
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Asthma Control Test

  6 months post start of intervention

• FEV1% Predicted

  Baseline to 6 months

• Changes in Medication Adherence and Lung Function

  Baseline to 6 months post start of intervention

• Number of Participants With Visits to ER for Asthma

  Baseline to 6 months post start of intervention

• Number of Missed Days of School

  Last 30 days from baseline visit and last 30 days from 6-month follow-up visit

Study Arms (2)

BreatheSmart System

EXPERIMENTAL

* 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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

BreatheSmart System DEVICE

* 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

BreatheSmart System

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (2)

• 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.

  PMID: 35691614 DERIVED

• 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.

  PMID: 33644492 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The intervention sample size was limited by the number of EMDs provided by CoHero. In addition, EMD adherence rates cannot directly be compared between the intervention and control groups because of the study design. Furthermore, at the initiation of the study, CoHero had not designed the BreatheSmart app for compatibility with Android smartphones. Thus, a significant proportion of potentially eligible children were18 excluded because of Android phone ownership.

Results Point of Contact

• Title: Dr. Jessica Hollenbach, PhD
• Organization: Connecticut Children's Medical Center, Asthma Center

jhollenbach@connecticutchildrens.org

860-837-5333

Study Officials

• Tregony Simoneau, MD

  Connecticut Childrens Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to one of two arms: 1. BreathSmart system 2. Standard of Care

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: November 8, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)