AsthmaNCT03860519
The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma
A study testing Electronic Medication Monitors on ICS and SABA - Active Mode, Electronic Medication Monitors on ICS and SABA - Silent Mode and Asthma App Tracking of ICS/SABA Usage - Active Mode in people with Asthma, run by Endeavor Health at 1 site in United States.
Trial summary
This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic Medication Monitors on ICS and SABA - Active Mode, Electronic Medication Monitors on ICS and SABA - Silent Mode and Asthma App Tracking of ICS/SABA Usage - Active Mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
- Have an active NorthShore Connect (patient portal) account
- Persistent uncontrolled asthma in the past 12 months
- Active prescription for daily ICS medication for asthma
Who cannot join
- candidate refusal
- the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.
- Conditions
- Asthma
- Being tested
- Electronic Medication Monitors on ICS and SABA - Active Mode, Electronic Medication Monitors on ICS and SABA - Silent Mode, Asthma App Tracking of ICS/SABA Usage - Active Mode, Asthma App Tracking of ICS/SABA Usage - Silent Mode, NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes
- Keywords
- asthma, uncontrolled asthma, asthma medication adherence, Propeller Health, Connected Inhaler System
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Medication Monitors on ICS and SABA - Active ModeBehavioural
Also called MDI, Diskus
The patients in the intervention group will have sensors that are "active", so that these patients receive reminders about when to use their inhalers medications.
Electronic Medication Monitors on ICS and SABA - Silent ModeBehavioural
Also called MDI, Diskus
The patients in the control group will have sensors that are "silent", so that these patients do not receive reminders about when to use their inhalers medications.
Asthma App Tracking of ICS/SABA Usage - Active ModeBehavioural
Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
Asthma App Tracking of ICS/SABA Usage - Silent ModeBehavioural
Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
NorthShore Connect Real Time ICS and SABA Usage Feedback - YesBehavioural
Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.
NorthShore Connect Real Time ICS and SABA Usage Feedback - NoBehavioural
Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status.
Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - YesBehavioural
Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - NoBehavioural
Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard). Receives: Behavioral: Electronic Medication Monitors on ICS and SABA - Active Mode; Behavioral: Asthma App Tracking of ICS/SABA Usage - Active Mode; Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes; Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes |
| Control Group | Experimental | The control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed. Receives: Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode; Behavioral: Asthma App Tracking of ICS/SABA Usage - Silent Mode; Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - No; Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off
Use of the Propeller Health Platform in the treatment group in active mode, compared to the attention control group in silent mode, will demonstrate a 20% change in SABA use and/or minimal clinically important difference (three points) change on the ACT and/or change from ACT score ≤ 19 to ≥20, at 3-months. The 20% change in SABA use = 20 point change (e.g. if a participants uses SABA 40% of days over the 2 week run-in period, and they change SABA use to 20% of days during the final 14 days of the active treatment period, that will equal a 20 point change. If SABA use changes from 40% of days over the 2- week run-in period to 32% of days during the final 14 days of the active treatment period, this will not be considered a 20 point change).
Measured: 3.5 months
Secondary outcomes (2)
Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology
Study staff developed a brief survey using open-ended questions (i.e. 20 questions, no scales used, no minimum or maximum scores are applicable) to ask participants and clinicians whether they were satisfied using the Propeller Health Platform Digital Technology. Standardized instruments are not being used.
Measured: 3.5 months
Inhaled Corticosteroid Medication taking Behavior in the Group using Propeller Health Platform Digital Technology Turned On vs Group using Propeller Health Platform Digital Technology Turned Off
To determine if two Propeller Health Platform Digital Technology arms (i.e. Arm #1= Technology in active "on" mode and Arm #2= Technology in passive "off" mode) demonstrate a change in inhaled corticosteroid medication taking behavior at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start7 Mar 2018
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Mosnaim, Endeavor Health
- Investigators
- Giselle Mosnaim, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860519
- Sponsor's protocol ID
- EH17-322
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2018
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, Szefler S. Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta2-agonists in uncontrolled asthma. J Asthma. 2022 Oct;59(10):2024-2027. doi: 10.1080/02770903.2021.1996600. Epub 2021 Nov 2.
PubMed 34699302
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
- ClinicalTrials.gov ID
- NCT03860519
- Acronym / sponsor ID
- EH17-322
- Conditions
- Asthma
- Keywords
- asthma, uncontrolled asthma, asthma medication adherence, Propeller Health, Connected Inhaler System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Electronic Medication Monitors on ICS and SABA - Active Mode, Behavioral: Asthma App Tracking of ICS/SABA Usage - Active Mode, Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes, Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - YesThe components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard). |
| Control Group | Experimental | Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode, Behavioral: Asthma App Tracking of ICS/SABA Usage - Silent Mode, Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - No, Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - NoThe control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
- Have an active NorthShore Connect (patient portal) account
- Persistent uncontrolled asthma in the past 12 months
- Active prescription for daily ICS medication for asthma
Key exclusion criteria (2 listed)
- candidate refusal
- the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
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 |
|---|---|---|
| Electronic Medication Monitors on ICS and SABA - Active ModeAlso: MDI, DiskusThe patients in the intervention group will have sensors that are "active", so that these patients receive reminders about when to use their inhalers medications. | Behavioural | Intervention Group |
| Electronic Medication Monitors on ICS and SABA - Silent ModeAlso: MDI, DiskusThe patients in the control group will have sensors that are "silent", so that these patients do not receive reminders about when to use their inhalers medications. | Behavioural | Control Group |
| Asthma App Tracking of ICS/SABA Usage - Active ModePatients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications. | Behavioural | Intervention Group |
| Asthma App Tracking of ICS/SABA Usage - Silent ModePatients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications. | Behavioural | Control Group |
| NorthShore Connect Real Time ICS and SABA Usage Feedback - YesPatients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status. | Behavioural | Intervention Group |
| NorthShore Connect Real Time ICS and SABA Usage Feedback - NoPatients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status. | Behavioural | Control Group |
| Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - YesPatients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform. | Behavioural | Intervention Group |
| Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - NoPatients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform. | Behavioural | Control Group |
Primary outcome
Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off
Time frame: 3.5 months
Use of the Propeller Health Platform in the treatment group in active mode, compared to the attention control group in silent mode, will demonstrate a 20% change in SABA use and/or minimal clinically important difference (three points) change on the ACT and/or change from ACT score ≤ 19 to ≥20, at 3-months. The 20% change in SABA use = 20 point change (e.g. if a participants uses SABA 40% of days over the 2 week run-in period, and they change SABA use to 20% of days during the final 14 days of the active treatment period, that will equal a 20 point change. If SABA use changes from 40% of days over the 2- week run-in period to 32% of days during the final 14 days of the active treatment period, this will not be considered a 20 point change).
2 secondary outcomes
Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology
Time frame: 3.5 months
Inhaled Corticosteroid Medication taking Behavior in the Group using Propeller Health Platform Digital Technology Turned On vs Group using Propeller Health Platform Digital Technology Turned Off
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 34699302Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, Szefler S. Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta2-agonists in uncontrolled asthma. J Asthma. 2022 Oct;59(10):2024-2027. doi: 10.1080/02770903.2021.1996600. Epub 2021 Nov 2.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
Giselle Mosnaim, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Medication Monitors on ICS and SABA - Active Mode, Electronic Medication Monitors on ICS and SABA - Silent Mode and Asthma App Tracking of ICS/SABA Usage - Active Mode in people with Asthma, run by Endeavor Health 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 4 inclusion and 2 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 3 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off (time frame: 3.5 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 NCT03860519, 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 3 Apr 2020.