Trial Outcomes & Findings for Asthma Data Innovation Demonstration Project (NCT NCT02162576)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

Change from baseline to study exit, up to 13 months

Results posted on

2021-07-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	95
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Asthma Data Innovation Demonstration Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propeller Health Intervention Group n=95 Participants 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).
Age, Categorical <=18 years	42 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	27.5 years STANDARD_DEVIATION 18.3 • n=5 Participants
Sex/Gender, Customized Female	53 participants n=5 Participants
Sex/Gender, Customized Male	42 participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants
Asthma Control Test	17.51 units on a scale STANDARD_DEVIATION 4.45 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Propeller Health Intervention Group n=95 Participants 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).
Change in Rescue Inhaler Actuations/Person/Day	-0.37 puffs per participant per day Standard Deviation 0.27

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Propeller Health Intervention Group n=95 Participants 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).
Percent Change in the Proportion of Participants With an Asthma-free Day	23 percentage change

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Propeller Health Intervention Group n=95 Participants 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).
Percent Change in the Proportion of Participants With Well-controlled Asthma	33 percent change

Adverse Events

Propeller Health Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Meredith Barrett

Propeller Health

Phone: 415-409-9258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place