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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01509183
Other study ID # 2011-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date September 2016

Study information

Verified date July 2021
Source Reciprocal Labs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 495
Est. completion date September 2016
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 5 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Woodland Medical Center Woodland California

Sponsors (2)

Lead Sponsor Collaborator
Reciprocal Labs California HealthCare Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Merchant RK, Inamdar R, Quade RC. Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):455-63. doi: 10.1016/j.jaip.2015.11.022. Epub 2016 Jan — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mean SABA Use 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 Change in the Proportion of SABA-free Days From Baseline to 12 Months Evaluate the change in the proportion of SABA-free days from baseline to 12 months Baseline to 12 months
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