Asthma, Bronchial Diseases, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Hypersensitivity, Respiratory Tract Diseases
Conditions
Keywords
asthma, asthma control, healthcare utilization costs, community hotspots, public health research
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.
Interventions
DEVICEPropeller Health intervention
The Propeller intervention works through the provision of information to patients and their providers. With the Propeller sensor device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp and geographic location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. This communication provides an ongoing assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management. Each participant was invited to share reports with his or her healthcare provider, but this was not required.
Sponsors
Foundation for a Healthy Kentucky
Norton Healthcare Foundation
Owsley Brown Charitable Foundation
David Van Sickle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The study recruited residents from community events, clinics and retail pharmacies using a convenience sampling strategy. Participants were eligible if they reported a physician diagnosis of asthma and a current prescription for SABA medication. Recruitment occurred between 6/2012 and 1/2013, with the last subject exiting the program in 1/2014.
Pre-assignment details
A run-in period of 30 days was designed to limit enrollment to those participants who could comply with the study requirements. In order to be included in the study, the participant would have to 1) create an account, 2) activate their sensor, and 3) remain active (defined by sensor syncing) for the first 30 day run-in period.
Participants by arm
| Arm | Count |
|---|---|
| Propeller Health Intervention Group 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). | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | Propeller Health Intervention Group |
|---|---|
| Age, Categorical <=18 years | 42 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 27.5 years STANDARD_DEVIATION 18.3 |
| Asthma Control Test | 17.51 units on a scale STANDARD_DEVIATION 4.45 |
| Region of Enrollment United States | 95 participants |
| Sex/Gender, Customized Female | 53 participants |
| Sex/Gender, Customized Male | 42 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
Change in Rescue Inhaler Actuations/Person/Day
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.
Time frame: Change from baseline to study exit, up to 13 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Propeller Health Intervention Group | Change in Rescue Inhaler Actuations/Person/Day | -0.37 puffs per participant per day | Standard Deviation 0.27 |
Secondary
Percent Change in the Proportion of Participants With an Asthma-free Day
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.
Time frame: Change from baseline period to study exit (approximately 13 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propeller Health Intervention Group | Percent Change in the Proportion of Participants With an Asthma-free Day | 23 percentage change |
Secondary
Percent Change in the Proportion of Participants With Well-controlled Asthma
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.
Time frame: Baseline and study exit (approximately 13 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propeller Health Intervention Group | Percent Change in the Proportion of Participants With Well-controlled Asthma | 33 percent change |