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Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propeller Health System (formerly Asthmapolis System)
Sponsored by
Reciprocal Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, healthcare utilization costs

Eligibility Criteria

5 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Woodland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).

Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.

Outcomes

Primary Outcome Measures

Change in Mean SABA Use
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2012
Last Updated
July 16, 2021
Sponsor
Reciprocal Labs
Collaborators
California HealthCare Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01509183
Brief Title
Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
Official Title
Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reciprocal Labs
Collaborators
California HealthCare Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, healthcare utilization costs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
Intervention Type
Device
Intervention Name(s)
Propeller Health System (formerly Asthmapolis System)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Mean SABA Use
Description
Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).
Time Frame
Change in mean SABA use over the course of 12 months
Secondary Outcome Measure Information:
Title
Change in the Proportion of SABA-free Days From Baseline to 12 Months
Description
Evaluate the change in the proportion of SABA-free days from baseline to 12 months
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajan K Merchant, MD
Organizational Affiliation
Catholic Healthcare West Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woodland Medical Center
City
Woodland
State/Province
California
ZIP/Postal Code
95695
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26778246
Citation
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 8.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26778246/
Description
Publication

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Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System

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