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Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System

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ClinicalTrials.gov Identifier: NCT01509183
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
California HealthCare Foundation
Information provided by (Responsible Party):
Reciprocal Labs

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Device: Propeller Health System (formerly Asthmapolis System) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
Study Start Date : April 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509183


Locations
United States, California
Woodland Medical Center
Woodland, California, United States, 95695
Sponsors and Collaborators
Reciprocal Labs
California HealthCare Foundation
Investigators
Principal Investigator: Rajan K Merchant, MD Catholic Healthcare West Medical Foundation

Responsible Party: Reciprocal Labs
ClinicalTrials.gov Identifier: NCT01509183     History of Changes
Other Study ID Numbers: 2011-10
First Posted: January 12, 2012    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Reciprocal Labs:
asthma
healthcare utilization costs