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Study to Determine the Impact of BreatheSmart on Asthma Control in Adult Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BreatheSmart
Sponsored by
CoheroHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Patient Adherence, Mobile Applications, Mobile Health, Medication Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and/or female adults (aged ≥ 18 years) Ability to provide written informed consent Owns a compatible smartphone (iOS 8.0 or higher, or Android 4.3 or higher) and is familiar with the download and management of software applications Diagnosis of persistent asthma for at least 6 months duration with evidence of poorly controlled disease defined as having at least one of the following within 12 months prior to consent: exacerbation of asthma symptoms requiring pulse of corticosteroids acute asthma event that resulted in an emergency department or urgent care visit hospitalization for asthma related care Managed on inhaled corticosteroid (ICS) medication for at least 3 months prior to enrollment. Stable dose of oral corticosteroids and/or biologic therapy is also permissable Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker Non-smoker, or ≤ 10 pack/year history of tobacco use and abstinence for at least 1 year Exclusion Criteria: Presence of other significant chronic lung disease or condition such as chronic obstructive pulmonary disease, cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, primary pulmonary hypertension, or presence of tracheostomy Presence of other chronic medical conditions such as congenital heart disease or immunodeficiency, Presence of other comorbidities that, in the opinion of the investigator, will interfere with the collection of study procedures, or limit life expectancy to < 1 year Currently pregnant/breast feeding or planning to become pregnant during the study period Primary language other than English or Spanish

Sites / Locations

  • North Westchester Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BreatheSmart Intervention

Arm Description

104 subjects will be provided with the BreatheSmart Platform, which consists of: HeroTracker asthma sensor that counts asthma dosage and monitors real-time medication adherence Mobile Spirometer that offers remote clinical-grade lung function monitoring BreatheSmart mobile application that provides patients with real-time alerts and allows patients to complete quality of life surveys

Outcomes

Primary Outcome Measures

Change in asthma control
Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
Change in rescue medication usage
Determine change in rescue medication usage in subjects using the BreatheSmart system from baseline to 3 months.

Secondary Outcome Measures

Change in controller medication adherence
We plan to obtain the medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline, 1 month post-baseline, 2-months post-baseline, and 3-months post-baseline. We will then display the monthly averaged medication treatment adherence and calculate the difference in medication adherence between baseline and 3-months post-baseline, which will be expressed as a percentage increase or decrease.

Full Information

First Posted
January 15, 2023
Last Updated
January 26, 2023
Sponsor
CoheroHealth
Collaborators
Databean
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1. Study Identification

Unique Protocol Identification Number
NCT05712863
Brief Title
Study to Determine the Impact of BreatheSmart on Asthma Control in Adult Asthmatics
Official Title
A Prospective, Observational Study to Assess Changes in Asthma Control in Adults With Asthma Managed on BreatheSmart
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoheroHealth
Collaborators
Databean

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, observational study of adults with persistent asthma who are managed on inhaled corticosteroids (ICS).
Detailed Description
This is a prospective, observational study of adults with persistent asthma who are managed on inhaled corticosteroids (ICS). The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes: HeroTracker sensor that counts dosage and monitors real-time medication adherence Mobile Spirometer that offers remote clinical-grade lung function monitoring BreatheSmart mobile application that sends subjects real-time alerts and allow patients to enter quality of life data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Patient Adherence, Mobile Applications, Mobile Health, Medication Compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BreatheSmart Intervention
Arm Type
Experimental
Arm Description
104 subjects will be provided with the BreatheSmart Platform, which consists of: HeroTracker asthma sensor that counts asthma dosage and monitors real-time medication adherence Mobile Spirometer that offers remote clinical-grade lung function monitoring BreatheSmart mobile application that provides patients with real-time alerts and allows patients to complete quality of life surveys
Intervention Type
Device
Intervention Name(s)
BreatheSmart
Intervention Description
BreatheSmart is a comprehensive asthma monitoring system combining medical devices and a mobile application designed for use with iOS and Android operating systems. Using Bluetooth to connect, the devices sync with the mobile application to facilitate the collection of medication adherence and lung function data.
Primary Outcome Measure Information:
Title
Change in asthma control
Description
Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
Time Frame
3 months
Title
Change in rescue medication usage
Description
Determine change in rescue medication usage in subjects using the BreatheSmart system from baseline to 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in controller medication adherence
Description
We plan to obtain the medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline, 1 month post-baseline, 2-months post-baseline, and 3-months post-baseline. We will then display the monthly averaged medication treatment adherence and calculate the difference in medication adherence between baseline and 3-months post-baseline, which will be expressed as a percentage increase or decrease.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and/or female adults (aged ≥ 18 years) Ability to provide written informed consent Owns a compatible smartphone (iOS 8.0 or higher, or Android 4.3 or higher) and is familiar with the download and management of software applications Diagnosis of persistent asthma for at least 6 months duration with evidence of poorly controlled disease defined as having at least one of the following within 12 months prior to consent: exacerbation of asthma symptoms requiring pulse of corticosteroids acute asthma event that resulted in an emergency department or urgent care visit hospitalization for asthma related care Managed on inhaled corticosteroid (ICS) medication for at least 3 months prior to enrollment. Stable dose of oral corticosteroids and/or biologic therapy is also permissable Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker Non-smoker, or ≤ 10 pack/year history of tobacco use and abstinence for at least 1 year Exclusion Criteria: Presence of other significant chronic lung disease or condition such as chronic obstructive pulmonary disease, cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, primary pulmonary hypertension, or presence of tracheostomy Presence of other chronic medical conditions such as congenital heart disease or immunodeficiency, Presence of other comorbidities that, in the opinion of the investigator, will interfere with the collection of study procedures, or limit life expectancy to < 1 year Currently pregnant/breast feeding or planning to become pregnant during the study period Primary language other than English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Tam
Organizational Affiliation
Consultant
Official's Role
Study Director
Facility Information:
Facility Name
North Westchester Hospital
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19183166
Citation
Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.
Results Reference
background
PubMed Identifier
25840665
Citation
Chan AH, Harrison J, Black PN, Mitchell EA, Foster JM. Using electronic monitoring devices to measure inhaler adherence: a practical guide for clinicians. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):335-49.e1-5. doi: 10.1016/j.jaip.2015.01.024. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
19767070
Citation
Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
Results Reference
background
PubMed Identifier
23058645
Citation
Jia CE, Zhang HP, Lv Y, Liang R, Jiang YQ, Powell H, Fu JJ, Wang L, Gibson PG, Wang G. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol. 2013 Mar;131(3):695-703. doi: 10.1016/j.jaci.2012.08.023. Epub 2012 Oct 8.
Results Reference
background
PubMed Identifier
22401649
Citation
Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, Di Franco A, Malagrino L, Novelli F, Vagaggini B, Paggiaro P. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012 Apr;49(3):317-23. doi: 10.3109/02770903.2012.661008. Epub 2012 Mar 9.
Results Reference
background
PubMed Identifier
22123375
Citation
Korn S, Both J, Jung M, Hubner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria. Ann Allergy Asthma Immunol. 2011 Dec;107(6):474-9. doi: 10.1016/j.anai.2011.09.001. Epub 2011 Oct 5.
Results Reference
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Study to Determine the Impact of BreatheSmart on Asthma Control in Adult Asthmatics

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