Skip to main content
OpenTrials
Completed

NCT Number: NCT03860519

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: MDI, Diskus

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.

Other names: MDI, Diskus

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.

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.

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.

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.

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.