The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma

Study Overview
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Brief Summary
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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.

Official Title
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The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Electronic Medication Monitors on ICS and SABA - Active Mode
* Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode
* Behavioral: Asthma App Tracking of ICS/SABA Usage - Active Mode
* Behavioral: Asthma App Tracking of ICS/SABA Usage - Silent Mode
* Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes
* Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - No
* Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes
* Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: candidate refusal the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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). | Behavioral: Electronic Medication Monitors on ICS and SABA - Active Mode<br>* 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.<br>* Other names: MDI, Diskus;Behavioral: Asthma App Tracking of ICS/SABA Usage - Active Mode<br>* Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.<br>Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes<br>* Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.<br>Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes<br>* Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.<br>|
| Experimental: Control Group<br>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. | Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode<br>* 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.<br>* Other names: MDI, Diskus;Behavioral: Asthma App Tracking of ICS/SABA Usage - Silent Mode<br>* Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.<br>Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - No<br>* Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status.<br>Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No<br>* Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, uncontrolled asthma, asthma medication adherence, Propeller Health, Connected Inhaler System