Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System

July 16, 2021 updated by: Reciprocal Labs

Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Propeller Health approach to asthma management. The Propeller Health goal is to bring together the best technology and asthma insight in order to provide Dignity Health with an engaging, data-driven chronic care program to improve asthma management and lower healthcare utilization costs, and to respond to prevention-focused reforms to health insurance laws.

This project has been designed to implement and evaluate a data-driven program to improve asthma management and control and lower direct costs through reductions in healthcare utilization. This program has been developed by Propeller Health and has gone through preliminary testing. Each subject participating in the study will receive an Propeller Health device, which captures the time and location of use of inhaled short-acting bronchodilators over a twelve-month period. This information is processed and delivered at regular intervals to the patient and his or her provider to support improved asthma management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to evaluate the impact of the adoption of the Propeller Health system into a healthcare organization, and to provide sufficient information to inform decision making for potential future adopters. The researchers believe that the Propeller Health system has the potential to improve asthma control by providing rescue inhaler actuation data and tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler actuation data to their providers. Improvements in asthma control should be reflected in reductions in healthcare utilization for asthma, and potentially for general healthcare utilization. Reductions in utilization would result in lower healthcare costs. The study has been designed to capture data on individual subject asthma control, and changes in utilization and costs over a one-year introduction period.

Study Type

Interventional

Enrollment (Actual)

495

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Woodland, California, United States, 95695
        • Woodland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provider diagnosis of asthma (ICD9 493.xx);
  • At least one healthcare utilization event in CHW within last 12 months; and
  • Prescription for Short Acting Beta Agonist (SABA) at study intake.

Exclusion Criteria:

  • Subject is under the age of 5 at the beginning of the study;
  • Subject does not speak either English or Spanish;
  • Subject does not have access to the Internet or email to receive reports; and
  • Subject has substantial co-morbidity (provider diagnosis of COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention Group
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Device: Propeller Health System (formerly Asthmapolis System)
The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
NO_INTERVENTION: Control Group
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean SABA Use
Time Frame: Change in mean SABA use over the course of 12 months
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
Change in mean SABA use over the course of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Proportion of SABA-free Days From Baseline to 12 Months
Time Frame: Baseline to 12 months
Evaluate the change in the proportion of SABA-free days from baseline to 12 months
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reciprocal Labs

Collaborators

California HealthCare Foundation

Investigators

  • Principal Investigator: Rajan K Merchant, MD, Catholic Healthcare West Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (ESTIMATE)

January 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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