An interventional study of Propeller Health intervention in Asthma, Bronchial Diseases and Respiratory Tract Diseases, sponsored by David Van Sickle. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by David Van Sickle · Not applicable, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 95 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with David Van Sickle as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Propeller 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.
Also known as: Asthmapolis
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
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)
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)
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.
| Milestone | Propeller Health Intervention Group |
|---|---|
| Started | 95 |
| Completed | 95 |
| Not completed | 0 |
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.
| puffs per participant per day | Propeller Health Intervention Group |
|---|---|
| Change in Rescue Inhaler Actuations/Person/Day | -0.37 ± 0.27 |
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.
| percentage change | Propeller Health Intervention |
|---|---|
| Percent Change in the Proportion of Participants With an Asthma-free Day | 23 |
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.
| percent change | Propeller Health Intervention |
|---|---|
| Percent Change in the Proportion of Participants With Well-controlled Asthma | 33 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propeller Health Intervention | — | 0/95 (0%) | 0/95 (0%) |
95 participants were enrolled in the study program.
| Age, Categorical(Participants) | Propeller Health Intervention Group |
|---|---|
| <=18 years | 42 |
| Between 18 and 65 years | 51 |
| >=65 years | 2 |
| Age, Continuous(years) | Propeller Health Intervention Group |
|---|---|
| Mean | 27.5 ± 18.3 |
| Sex/Gender, Customized(participants) | Propeller Health Intervention Group |
|---|---|
| Female | 53 |
| Male | 42 |
| Region of Enrollment(participants) | Propeller Health Intervention Group |
|---|---|
| United States | 95 |
| Asthma Control Test(units on a scale) | Propeller Health Intervention Group |
|---|---|
| Mean | 17.51 ± 4.45 |
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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