Effectiveness of the Asthmapolis Monitoring System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Reciprocal Labs.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
California HealthCare Foundation
Information provided by (Responsible Party):
Reciprocal Labs
ClinicalTrials.gov Identifier:
NCT01509183
First received: January 9, 2012
Last updated: July 23, 2012
Last verified: July 2012

January 9, 2012
July 23, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
  • Asthma control [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Asthma control [ Time Frame: Change from baseline at 8 months ] [ Designated as safety issue: No ]
  • Asthma control [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01509183 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of the Asthmapolis Monitoring System
Effectiveness of the Asthmapolis Monitoring System

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
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.
  • Active Comparator: Intervention Group
    Intervention: Device: Asthmapolis System
  • No Intervention: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 90 Years
No
United States
 
NCT01509183
2011-10
No
Reciprocal Labs
Reciprocal Labs
California HealthCare Foundation
Principal Investigator: Rajan K Merchant, MD Catholic Healthcare West Medical Foundation
Reciprocal Labs
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP