Asthma Data Innovation Demonstration Project

Not Applicable

Completed

Conditions: Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity
Immune System Diseases
Asthma
Lung Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Hypersensitivity, Immediate

Interventions: Device: Propeller Health intervention

Registration Number: NCT02162576

Lead Sponsor: David Van Sickle

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 95

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propeller Health intervention group	Propeller Health intervention	All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months (see intervention for description).

Primary Outcome Measures

Name	Time	Method
Change in Rescue Inhaler Actuations/Person/Day	Change from baseline to study exit, up to 13 months	The Propeller Health sensor permits the capture of objective time and location data on each actuation of the rescue inhaler. The mean number of rescue inhaler events per participant per day will be assessed for each day in the study, and the difference between the baseline month and all subsequent months will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Percent Change in the Proportion of Participants With an Asthma-free Day	Change from baseline period to study exit (approximately 13 months)	Each 24-hour period without an actuation of a rescue inhaler was counted as an asthma-free day. The proportion of participants with an asthma-free day was calculated for each day of the program, with the denominator including all active participants on that day of the program, defined as those that synced after that date.
Percent Change in the Proportion of Participants With Well-controlled Asthma	Baseline and study exit (approximately 13 months)	Daily control status was assessed based upon the timing and frequency of SABA actuations according to NAEPP guidelines. The proportion of the study cohort defined as well controlled, not well controlled and poorly controlled was assessed weekly throughout the program.