Trial Outcomes & Findings for Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System (NCT NCT01509183)
NCT ID: NCT01509183
Last Updated: 2021-07-20
Results Overview
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
495 participants
Primary outcome timeframe
Change in mean SABA use over the course of 12 months
Results posted on
2021-07-20
Participant Flow
Participants were recruited between April 2012 \& June 2013 via an asthma registry, community outreach efforts, and provider referrals.
Participant milestones
| Measure |
Intervention Group
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
|
Control Group
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
245
|
|
Overall Study
COMPLETED
|
141
|
134
|
|
Overall Study
NOT COMPLETED
|
109
|
111
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
Baseline characteristics by cohort
| Measure |
Intervention Group
n=250 Participants
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
|
Control Group
n=245 Participants
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
|
Total
n=495 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
163 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in mean SABA use over the course of 12 monthsMean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
Outcome measures
| Measure |
Intervention Group
n=250 Participants
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
|
Control Group
n=245 Participants
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
|
|---|---|---|
|
Change in Mean SABA Use
|
-0.41 mean puffs per day
Standard Deviation 0.69
|
-0.31 mean puffs per day
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsEvaluate the change in the proportion of SABA-free days from baseline to 12 months
Outcome measures
| Measure |
Intervention Group
n=250 Participants
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
|
Control Group
n=245 Participants
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
|
|---|---|---|
|
Change in the Proportion of SABA-free Days From Baseline to 12 Months
|
21 % Change in proportion of SABA-free days
|
17 % Change in proportion of SABA-free days
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place