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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode; Behavioral: Electronic Medication Monitors on ICS and SABA - Active 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 - No; Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes; Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes; Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No

• Registration Number: NCT03860519
• Lead Sponsor: NorthShore University HealthSystem

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-07
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Electronic Medication Monitors on ICS and SABA - Silent Mode	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.
Intervention Group	Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes	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).
Intervention Group	Electronic Medication Monitors on ICS and SABA - Active Mode	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).
Control Group	NorthShore Connect Real Time ICS and SABA Usage Feedback - No	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.
Intervention Group	Asthma App Tracking of ICS/SABA Usage - Active Mode	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).
Control Group	Asthma App Tracking of ICS/SABA Usage - Silent Mode	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.
Intervention Group	NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes	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).
Control Group	Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No	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.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology	3.5 months	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.
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	3 months	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.

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States