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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Medication Monitors on ICS and SABA - Active Mode | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giselle Mosnaim, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34699302 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Electronic Medication Monitors on ICS and SABA - Silent Mode | Behavioral | 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. |
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| Asthma App Tracking of ICS/SABA Usage - Active Mode | Behavioral | Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications. |
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| Asthma App Tracking of ICS/SABA Usage - Silent Mode | Behavioral | Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications. |
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| NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes | Behavioral | Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status. |
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| NorthShore Connect Real Time ICS and SABA Usage Feedback - No | Behavioral | Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status. |
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| Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes | Behavioral | Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform. |
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| Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No | Behavioral | Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform. |
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| 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. | 3 months |
| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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