AsthmaNCT01509183
Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
A study testing Propeller Health System (formerly Asthmapolis System) in people with Asthma, run by Reciprocal Labs at 1 site in United States.
Trial summary
Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Propeller Health approach to asthma management. Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- Asthma
- What is being tested?
- Propeller Health System (formerly Asthmapolis System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provider diagnosis of asthma (ICD9 493.xx);
- At least one healthcare utilization event in CHW within last 12 months; and
- Prescription for Short Acting Beta Agonist (SABA) at study intake.
Who cannot join
- Subject is under the age of 5 at the beginning of the study;
- Subject does not speak either English or Spanish;
- Subject does not have access to the Internet or email to receive reports; and
- Subject has substantial co-morbidity (provider diagnosis of COPD
Trial locations and contacts
1 site in 1 country.
About this study
Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Propeller Health approach to asthma management. The Propeller Health goal is to bring together the best technology and asthma insight in order to provide Dignity Health with an engaging, data-driven chronic care program to improve asthma management and lower healthcare utilization costs, and to respond to prevention-focused reforms to health insurance laws.
This project has been designed to implement and evaluate a data-driven program to improve asthma management and control and lower direct costs through reductions in healthcare utilization. This program has been developed by Propeller Health and has gone through preliminary testing. Each subject participating in the study will receive an Propeller Health device, which captures the time and location of use of inhaled short-acting bronchodilators over a twelve-month period. This information is processed and delivered at regular intervals to the patient and his or her provider to support improved asthma management.
Read the detailed description
The purpose of the study is to evaluate the impact of the adoption of the Propeller Health system into a healthcare organization, and to provide sufficient information to inform decision making for potential future adopters. The researchers believe that the Propeller Health system has the potential to improve asthma control by providing rescue inhaler actuation data and tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler actuation data to their providers. Improvements in asthma control should be reflected in reductions in healthcare utilization for asthma, and potentially for general healthcare utilization. Reductions in utilization would result in lower healthcare costs. The study has been designed to capture data on individual subject asthma control, and changes in utilization and costs over a one-year introduction period.
- Conditions
- Asthma
- Being tested
- Propeller Health System (formerly Asthmapolis System)
- Keywords
- asthma, healthcare utilization costs
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propeller Health System (formerly Asthmapolis System)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System). Receives: Device: Propeller Health System (formerly Asthmapolis System) |
| Control Group | No intervention | Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean SABA Use
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
Measured: Change in mean SABA use over the course of 12 months
Secondary outcomes (1)
Change in the Proportion of SABA-free Days From Baseline to 12 Months
Evaluate the change in the proportion of SABA-free days from baseline to 12 months
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reciprocal Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California HealthCare Foundation
- Responsible party
- Sponsor
- Investigators
- Rajan K Merchant, MD, Principal investigator, Catholic Healthcare West Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509183
- Sponsor's protocol ID
- 2011-10
- Status last verified
- Jul 2021
- First submitted
- 9 Jan 2012
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Merchant RK, Inamdar R, Quade RC. Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):455-63. doi: 10.1016/j.jaip.2015.11.022. Epub 2016 Jan 8.
PubMed 26778246
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
- ClinicalTrials.gov ID
- NCT01509183
- Acronym / sponsor ID
- 2011-10
- Conditions
- Asthma
- Keywords
- asthma, healthcare utilization costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Reciprocal LabsIndustry (pharma, biotech, devices)
- Collaborators
- California HealthCare Foundation
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Posted 13 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Propeller Health approach to asthma management. The Propeller Health goal is to bring together the best technology and asthma insight in order to provide Dignity Health with an engaging, data-driven chronic care program to improve asthma management and lower healthcare utilization costs, and to respond to prevention-focused reforms to health insurance laws.
This project has been designed to implement and evaluate a data-driven program to improve asthma management and control and lower direct costs through reductions in healthcare utilization. This program has been developed by Propeller Health and has gone through preliminary testing. Each subject participating in the study will receive an Propeller Health device, which captures the time and location of use of inhaled short-acting bronchodilators over a twelve-month period. This information is processed and delivered at regular intervals to the patient and his or her provider to support improved asthma management.
Detailed description
The purpose of the study is to evaluate the impact of the adoption of the Propeller Health system into a healthcare organization, and to provide sufficient information to inform decision making for potential future adopters. The researchers believe that the Propeller Health system has the potential to improve asthma control by providing rescue inhaler actuation data and tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler actuation data to their providers. Improvements in asthma control should be reflected in reductions in healthcare utilization for asthma, and potentially for general healthcare utilization. Reductions in utilization would result in lower healthcare costs. The study has been designed to capture data on individual subject asthma control, and changes in utilization and costs over a one-year introduction period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Propeller Health System (formerly Asthmapolis System)Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System). |
| Control Group | No intervention | –Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback. |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Provider diagnosis of asthma (ICD9 493.xx);
- At least one healthcare utilization event in CHW within last 12 months; and
- Prescription for Short Acting Beta Agonist (SABA) at study intake.
Key exclusion criteria (4 listed)
- Subject is under the age of 5 at the beginning of the study;
- Subject does not speak either English or Spanish;
- Subject does not have access to the Internet or email to receive reports; and
- Subject has substantial co-morbidity (provider diagnosis of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
Primary outcome
Change in Mean SABA Use
Time frame: Change in mean SABA use over the course of 12 months
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
1 secondary outcome
Change in the Proportion of SABA-free Days From Baseline to 12 Months
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26778246Merchant RK, Inamdar R, Quade RC. Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):455-63. doi: 10.1016/j.jaip.2015.11.022. Epub 2016 Jan 8.
- PublicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajan K Merchant, MD principal investigator
Catholic Healthcare West Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propeller Health System (formerly Asthmapolis System) in people with Asthma, run by Reciprocal Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean SABA Use (time frame: Change in mean SABA use over the course of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.