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

• ClinicalTrials.gov Identifier: NCT03860519
• Recruitment Status: Completed
• First Posted: March 4, 2019
• Last Update Posted: April 3, 2020
• Sponsor: NorthShore University HealthSystem
• Information provided by (Responsible Party): Giselle Mosnaim, NorthShore University HealthSystem

Tracking Information

• First Submitted Date: September 26, 2018
• First Posted Date: March 4, 2019
• Last Update Posted Date: April 3, 2020
• Actual Study Start Date: March 7, 2018
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2019)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 28, 2019)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma
• Official Title: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
  Other Name: MDI, Diskus
• 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 - 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: 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 - Yes
  Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.
• 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 - Yes
  Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
• 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.

Study Arms

• 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).
  Interventions:

  • Behavioral: Electronic Medication Monitors on ICS and SABA - Active Mode
  • Behavioral: Asthma App Tracking of ICS/SABA Usage - Active Mode
  • Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes
  • Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes
• 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.
  Interventions:

  • Behavioral: Electronic Medication Monitors on ICS and SABA - Silent Mode
  • Behavioral: Asthma App Tracking of ICS/SABA Usage - Silent Mode
  • Behavioral: NorthShore Connect Real Time ICS and SABA Usage Feedback - No
  • Behavioral: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No

• Publications *: Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, Szefler S. Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta2-agonists in uncontrolled asthma. J Asthma. 2022 Oct;59(10):2024-2027. doi: 10.1080/02770903.2021.1996600. Epub 2021 Nov 2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2019): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 1, 2019
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03860519
• Other Study ID Numbers: EH17-322
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Giselle Mosnaim, NorthShore University HealthSystem
• Original Responsible Party: Same as current
• Current Study Sponsor: NorthShore University HealthSystem
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: NorthShore University HealthSystem
• Verification Date: April 2020