Clinical trial NCT03103880: Assessing the Use of Mobile Technology in Adult Asthma Patients
Official title: Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Patient adherence
Mobile application
Mobile health
Digital therapeutics
Digital health
Lead sponsor: CoheroHealth
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

Detailed description: 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:

1. HeroTracker sensor that counts dosage and monitors real-time medication adherence
2. BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Male and female adults (aged ≥ 18 years)
* Diagnosis of asthma for at least 6 months
* ICS (inhaled corticosteroid) use for at least 3 months
* Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker
* Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher)

Exclusion Criteria:

* Currently pregnant or planning to become pregnant during the study period
* Primary language other than English (BreatheSmart mobile app is currently available only in English)

Primary outcomes:
measure: Change in asthma control
timeFrame: 3 months
measure: Change in rescue medication usage
timeFrame: 3 months
Secondary outcomes:
measure: Change in controller medication adherence
timeFrame: 3 months
measure: Acceptability of BreatheSmart system
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Cohero Health, Inc.
state: New York
Study officials:
affiliation: Cohero Health, Inc.
name: Anne Tam, MPH
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
citation: Melvin E, Cushing A, Tam A, Kitada R, Manice M. Assessing the use of BreatheSmart(R) mobile technology in adult patients with asthma: a remote observational study. BMJ Open Respir Res. 2017 Aug 16;4(1):e000204. doi: 10.1136/bmjresp-2017-000204. eCollection 2017.