Asthma Data Innovation Demonstration Project (ADID)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02162576 |
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Recruitment Status :
Completed
First Posted : June 12, 2014
Results First Posted : December 26, 2017
Last Update Posted : July 20, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases | Device: Propeller Health intervention | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 95 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2012 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | January 2014 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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.
Other Name: Asthmapolis |
- Change in Rescue Inhaler Actuations/Person/Day [ Time Frame: 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.
- Percent Change in the Proportion of Participants With an Asthma-free Day [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162576
| United States, Kentucky | |
| Jefferson County | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | David Van Sickle, PhD | Propeller Health |
Publications of Results:
| Responsible Party: | David Van Sickle, CEO, Reciprocal Labs |
| ClinicalTrials.gov Identifier: | NCT02162576 |
| Other Study ID Numbers: |
PH LVL - 40202 |
| First Posted: | June 12, 2014 Key Record Dates |
| Results First Posted: | December 26, 2017 |
| Last Update Posted: | July 20, 2021 |
| Last Verified: | July 2021 |
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asthma asthma control healthcare utilization costs community hotspots public health research |
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Asthma Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Bronchial Diseases |
Respiratory Hypersensitivity Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |