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Effectiveness of the Asthmapolis Monitoring System

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ClinicalTrials.gov Identifier: NCT01509183
Recruitment Status : Unknown
Verified July 2012 by Reciprocal Labs.
Recruitment status was:  Recruiting
First Posted : January 12, 2012
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

Asthmapolis is collaborating with Catholic Healthcare West (CHW) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Asthmapolis approach to asthma management. The Asthmapolis goal is to bring together the best technology and asthma insight in order to provide CHW 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 Asthmapolis and has gone through preliminary testing. Each subject participating in the study will receive an Asthmapolis 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.

The purpose of the study is to evaluate the impact of the adoption of the Asthmapolis system into a healthcare organization, and to provide sufficient information to inform decision making for potential future adopters. The researchers believe that the Asthmapolis 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.

Condition or disease Intervention/treatment
Asthma Device: Asthmapolis System

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Asthmapolis Monitoring System
Study Start Date : January 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Intervention Group Device: Asthmapolis System
The Asthmapolis system works through the provision of information to patients and their providers. With the 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 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

Outcome Measures

Primary Outcome Measures :
  1. Asthma control [ Time Frame: Change from baseline at 4 months ]
  2. Asthma control [ Time Frame: Change from baseline at 8 months ]
  3. Asthma control [ Time Frame: Change from baseline at 12 months ]

Eligibility Criteria

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

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
Contacts and Locations

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

United States, California
Woodland Medical Center Recruiting
Woodland, California, United States, 95695
Contact: Jesika Riley    530-669-5633    jesika.riley@asthmapolis.com   
Sponsors and Collaborators
Reciprocal Labs
California HealthCare Foundation
Principal Investigator: Rajan K Merchant, MD Catholic Healthcare West Medical Foundation
More Information

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
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Reciprocal Labs:
healthcare utilization costs