Effectiveness of the Asthmapolis Monitoring System
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Purpose
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 | Intervention |
|---|---|
|
Asthma |
Device: Asthmapolis System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness of the Asthmapolis Monitoring System |
- 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 ]
| Estimated Enrollment: | 420 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 5 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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| United States, California | |
| Woodland Medical Center | Recruiting |
| Woodland, California, United States, 95695 | |
| Contact: Jesika Riley 530-669-5633 jesika.riley@asthmapolis.com | |
| Principal Investigator: | Rajan K Merchant, MD | Catholic Healthcare West Medical Foundation |
More Information
No publications provided
| Responsible Party: | Reciprocal Labs |
| ClinicalTrials.gov Identifier: | NCT01509183 History of Changes |
| Other Study ID Numbers: | 2011-10 |
| Study First Received: | January 9, 2012 |
| Last Updated: | July 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Reciprocal Labs:
|
asthma healthcare utilization costs |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013