Clinical trial NCT02162576: Asthma Data Innovation Demonstration Project
Official title: Asthma Data Innovation Demonstration Project: Impact of a Mobile Health, Sensor-driven Asthma Management Platform on Asthma Symptoms, Control and Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Keywords: asthma
asthma control
healthcare utilization costs
community hotspots
public health research
Lead sponsor: Reciprocal Labs
Sponsor class: INDUSTRY
Collaborators: name: Foundation for a Healthy Kentucky
name: Norton Healthcare Foundation
name: Owsley Brown Charitable Foundation
First posted: 2014-06-12
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Propeller Health is collaborating with the City of Louisville and other local partners to carry out a focused demonstration project that will evaluate the effectiveness of the Propeller Health approach to asthma management while exploring means to use real-time data on asthma exacerbations in a public health setting. The Asthma Data Innovation Demonstration Project (ADID) will use wireless sensor technology to develop spatial and temporal data on the use of rescue inhalers by 120 study subjects with asthma in the Louisville metropolitan area. Propeller Health will process these data to support two general strategies.

Asthma self management: Rescue inhaler actuation data will be compiled into individualized feedback reports to support asthma self management. Propeller Health will combine information on individual rescue inhaler actuations with evidence-based asthma management tips into real-time reports that will be provided to subjects. ADID staff will evaluate any resulting improvements in asthma control that may be based on this information. Subjects may share reports with their healthcare providers.

Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial and temporal asthma rescue inhaler actuation data to City personnel and authorized public health researchers in Louisville. These data will show the times and locations of the use of rescue inhalers by the 120 study subjects throughout the greater Louisville area. ADID staff will work with City personnel and researchers to investigate how this unprecedented level of detailed information on exacerbations can be used best to increase public awareness of environmental triggers while supporting public health surveillance efforts around respiratory diseases.


Eligibility criteria: Inclusion Criteria:

* Self-reported provider diagnosis of asthma
* Prescription for Short Acting Beta Agonist (SABA) at study intake

Exclusion Criteria:

* Subject is under the age of 5 at the beginning of the study
* Subject does not speak English
* Subject does not have access to the Internet or email to receive reports
* Subject has substantial co-morbidity (self-reported provider diagnosis of COPD)

Primary outcomes:
measure: Change in Rescue Inhaler Actuations/Person/Day
timeFrame: Change from baseline to study exit, up to 13 months
Secondary outcomes:
measure: Percent Change in the Proportion of Participants With an Asthma-free Day
timeFrame: Change from baseline period to study exit (approximately 13 months)
measure: Percent Change in the Proportion of Participants With Well-controlled Asthma
timeFrame: Baseline and study exit (approximately 13 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Jefferson County
state: Kentucky
Study officials:
affiliation: Propeller Health
name: David Van Sickle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett M, Combs V, Su JG, Henderson K, Tuffli M; AIR Louisville Collaborative; AIR Louisville Collaborative. AIR Louisville: Addressing Asthma With Technology, Crowdsourcing, Cross-Sector Collaboration, And Policy. Health Aff (Millwood). 2018 Apr;37(4):525-534. doi: 10.1377/hlthaff.2017.1315.
citation: Barrett MA, Humblet O, Marcus JE, Henderson K, Smith T, Eid N, Sublett JW, Renda A, Nesbitt L, Van Sickle D, Stempel D, Sublett JL. Effect of a mobile health, sensor-driven asthma management platform on asthma control. Ann Allergy Asthma Immunol. 2017 Nov;119(5):415-421.e1. doi: 10.1016/j.anai.2017.08.002.