NCT01509183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 13, 2018

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

January 9, 2012

Results QC Date

January 9, 2018

Last Update Submit

July 16, 2021

Conditions

Keywords

asthmahealthcare utilization costs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in the Proportion of SABA-free Days From Baseline to 12 Months

    Baseline to 12 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Device: Propeller Health System (formerly Asthmapolis System)

Control Group

NO INTERVENTION

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age5 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodland Medical Center

Woodland, California, 95695, United States

Location

Related 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 8.

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Research Team at Propeller Health
Organization
Propeller Health

Study Officials

  • Rajan K Merchant, MD

    Catholic Healthcare West Medical Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 12, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2014

Study Completion

September 1, 2016

Last Updated

July 20, 2021

Results First Posted

February 13, 2018

Record last verified: 2021-07

Locations