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

April 2, 2020 updated by: Giselle Mosnaim, NorthShore University HealthSystem

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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).
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
Time Frame: 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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Investigators

  • Principal Investigator: Giselle Mosnaim, MD, NorthShore University HealthSystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH17-322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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