The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2018
CompletedFirst Submitted
Initial submission to the registry
September 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedApril 3, 2020
April 1, 2020
1.3 years
September 26, 2018
April 2, 2020
Conditions
Keywords
Outcome Measures
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
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 Outcomes (2)
Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology
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
3 months
Study Arms (2)
Intervention Group
EXPERIMENTALThe 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).
Control Group
EXPERIMENTALThe 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
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.
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.
Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.
Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status.
Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- candidate refusal
- the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Related Publications (1)
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.
PMID: 34699302DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giselle Mosnaim, MD
Endeavor Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2018
First Posted
March 4, 2019
Study Start
March 7, 2018
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
April 3, 2020
Record last verified: 2020-04