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| Name | Class |
|---|---|
| Foundation for a Healthy Kentucky | OTHER |
| Norton Healthcare Foundation | OTHER |
| Owsley Brown Charitable Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propeller Health intervention group | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propeller Health intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to study exit, up to 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline period to study exit (approximately 13 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Van Sickle, PhD | Propeller Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson County | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29608361 | Result | 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. | |
| 29150069 | Result |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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95 participants were enrolled in the study program.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | puffs per participant per day | Change from baseline to study exit, up to 13 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propeller Health Intervention | After the control period is completed at 1 month, all participants will continue using their sensors, and will begin to receive the full intervention for 12 months. The intervention includes access to all of the participant's sensor-collected data, trends, educational information and weekly reports. The 13-month term was chosen in order to eliminate any seasonal variation in asthma exacerbations. Propeller Health: The digital sensor records rescue inhaler actuations, as well as time and date stamp, and location if available. Actuation data are then securely transmitted to Propeller Health where events and an assessment of asthma control can be viewed in secure online interfaces. 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. Each participant was invited to share reports with his or her healthcare provider, but this was not required. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meredith Barrett | Propeller Health | 415-409-9258 | meredith.barrett@propellerhealth.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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|
| 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. | Baseline and study exit (approximately 13 months) |
| 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Asthma Control Test | ACT is a patient self-administred tool for identifying those with poorly controlled asthma. There are 5 items, with 4-week recall, that address symptoms and daily functioning topics. Each item is measured on 5-point scale. The ACT score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Mean | Standard Deviation | units on a scale |
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| 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. | Posted | Number | percentage change | Change from baseline period to study exit (approximately 13 months) |
|
|
|
| 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. | Posted | Number | percent change | Baseline and study exit (approximately 13 months) |
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| 0 |
| 95 |
| 0 |
| 95 |
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