Asthma
Conditions
Keywords
asthma, uncontrolled asthma, asthma medication adherence, Propeller Health, Connected Inhaler System
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.
Interventions
BEHAVIORALElectronic 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.
BEHAVIORALElectronic 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.
BEHAVIORALAsthma 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.
BEHAVIORALAsthma 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.
BEHAVIORALNorthShore 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.
BEHAVIORALNorthShore 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.
BEHAVIORALAsthma 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.
BEHAVIORALAsthma 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.
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology | 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 | 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. |
Countries
United States
Outcome results
None listed