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

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ClinicalTrials.gov Identifier: NCT03860519
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Giselle Mosnaim, 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.

Condition or disease Intervention/treatment Phase
Asthma 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

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 Name: 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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860519


Contacts
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Contact: Brittney Adams, BS 224-364-7459 badams@northshore.org
Contact: Candy Gonzalez, BA 224-364-7456 cgonzalez@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Brittney Adams, BS    224-364-7459    badams@northshore.org   
Contact: Giselle Mosnaim, MD    224-364-7311    gmosnaim@northshore.org   
Principal Investigator: Giselle Mosnaim, MD         
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Giselle Mosnaim, MD NorthShore University HealthSystem

Additional Information:
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Responsible Party: Giselle Mosnaim, Principal Investigator, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT03860519     History of Changes
Other Study ID Numbers: EH17-322
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giselle Mosnaim, NorthShore University HealthSystem:
asthma
uncontrolled asthma
asthma medication adherence
Propeller Health
Connected Inhaler System

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases