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

NCT ID: NCT03860519

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-08-01

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Electronic Medication Monitors on ICS and SABA - Active Mode

Intervention Type BEHAVIORAL

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.

Asthma App Tracking of ICS/SABA Usage - Active Mode

Intervention Type BEHAVIORAL

Patients in the intervention group will 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

Intervention Type BEHAVIORAL

Patients in the intervention will 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

Intervention Type BEHAVIORAL

Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.

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.

Group Type EXPERIMENTAL

Electronic Medication Monitors on ICS and SABA - Silent Mode

Intervention Type BEHAVIORAL

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 - Silent Mode

Intervention Type BEHAVIORAL

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 - No

Intervention Type BEHAVIORAL

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 - No

Intervention Type BEHAVIORAL

Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MDI, Diskus MDI, Diskus

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Giselle Mosnaim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giselle Mosnaim, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34699302 (View on PubMed)

Other Identifiers

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EH17-322

Identifier Type: -

Identifier Source: org_study_id

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