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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860519
• Other study ID #: EH17-322
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2020
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

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