ADID: Asthma Data Innovation Demonstration Project

• Sponsor: David Van Sickle (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02162576
• Collaborator: Foundation for a Healthy Kentucky (Other), Norton Healthcare Foundation (Other), Owsley Brown Charitable Foundation (Other)
• Enrollment: 95
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: 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).

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 Names: Asthmapolis

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jefferson County	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• David Van Sickle
• Foundation for a Healthy Kentucky
• Norton Healthcare Foundation
• Owsley Brown Charitable Foundation

Investigators

• Principal Investigator: David Van Sickle, PhD, Propeller Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Feature by Robert Wood Johnson Foundation

Publications

None provided.

• Responsible Party: David Van Sickle, CEO, Reciprocal Labs
• ClinicalTrials.gov Identifier: NCT02162576
• Other Study ID Numbers: PH LVL - 40202
• First Posted: Jun 12, 2014
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by David Van Sickle, CEO, Reciprocal Labs: asthma; asthma control; healthcare utilization costs; community hotspots; public health research
• Additional relevant MeSH terms: Asthma; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate

Study Results

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 Detail	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.

Arm/Group Title	Propeller Health Intervention Group
Arm/Group Description	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).
Period Title: Overall Study
STARTED	95
COMPLETED	95
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Propeller Health Intervention Group
Arm/Group Description	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).
Overall Participants	95
Age (Count of Participants)
<=18 years	42 44.2%
Between 18 and 65 years	51 53.7%
>=65 years	2 2.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.5 (18.3)
Sex/Gender, Customized (participants) [Number]
Female	53 55.8%
Male	42 44.2%
Region of Enrollment (participants) [Number]
United States	95 100%
Asthma Control Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.51 (4.45)

Outcome Measures

1. Primary Outcome

Title	Change in Rescue Inhaler Actuations/Person/Day
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propeller Health Intervention Group
Arm/Group Description	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).
Measure Participants	95
Mean (Standard Deviation) [puffs per participant per day]	-0.37 (0.27)

2. Secondary Outcome

Title	Percent Change in the Proportion of Participants With an Asthma-free Day
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propeller Health Intervention
Arm/Group Description	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).
Measure Participants	95
Number [percentage change]	23

3. Secondary Outcome

Title	Percent Change in the Proportion of Participants With Well-controlled Asthma
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propeller Health Intervention
Arm/Group Description	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).
Measure Participants	95
Number [percent change]	33

Adverse Events

Arm/Group Title	Propeller Health Intervention
Arm/Group Description	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.
All Cause Mortality
	Propeller Health Intervention
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Propeller Health Intervention
	Affected / at Risk (%)	# Events
Total	0/95 (0%)
Other (Not Including Serious) Adverse Events
	Propeller Health Intervention
	Affected / at Risk (%)	# Events
Total	0/95 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.