- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993590
Mobile CHESS Research on Emergency Medical Services for Children
February 3, 2016 updated by: University of Wisconsin, Madison
The primary aims are to test whether an asthma care management system (M-CHESS) delivered via a smartphone (cellular phone with internet access) can support low income teenagers (ages 12-18) with significant asthma and can improve asthma control and reduce asthma-related emergency or urgent care visits and hospitalizations.
Secondary aims include whether M-CHESS increases adherence to asthma control medication and reduces absenteeism from school, work or an event they wanted to attend.
Study Overview
Detailed Description
Four hundred Milwaukee Medicaid recipients (ages 12-18), with an asthma-related emergency care visit or hospitalization in the last twelve months, will be recruited through their managed care organization (MCO).
They will be randomly assigned to one of two study arms and will participate in a 12-month intervention plus a 12-month follow-up period.
Subjects in the control group will receive a smartphone with internet access & text messaging service.
These devices will provide the ability to collect smartphone use data electronically.
The experimental group will also receive the same smartphone devices (with internet access and text messaging service and ability to collect usedata.
In addition the experimental group will have access to the Mobile CHESS (M-CHESS) interface.
The M-CHESS smartphone interface features an interactive, internet based asthma education program, peer support mechanisms and automated reminders for asthma control medicines and data collection.
Study Type
Interventional
Enrollment (Actual)
219
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53214
- Managed Health Services
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Milwaukee, Wisconsin, United States, 53226
- United Healthcare
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adolescents ranging in age from 12-18:
- These study candidates will have had an asthma related emergency care visit or hospitalization in the last 12 months and fit the following characteristics: an ICD-9 code 493.XX and have filled one or more prescription(s) for an asthma medication (short acting beta agonist, oral corticosteroid, inhaled or nebulized corticosteroid, long-acting beta agonist, xanthine, or leukotriene modifier).
- They also must receive medical care from one of the two participating managed care organizations involved in our study.
Exclusion Criteria:
- Other chronic pulmonary disorders such as cystic fibrosis, ABPA, or bronchopulmonary dysplasia.
- Developmental/cognitive/sensory disabilities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: M CHESS group
The intervention group will receive access for 12 months to M-CHESS via a smartphone to: (1) contact their case managers and primary provider; (2) communicate with the managed care organization case managers; (3) communicate with peers; (4) share information about changes in health status; (5) receive reminders to take medications and complete medical follow-up; (6) receive feedback on use of their asthma action plan; (7) receive tailored inquiries and insights regarding attendance or use of asthma resources; and (8) access audio and video versions of asthma educational materials and lower reading level versions of text materials; (9) provide monthly study outcome data monthly for 12 months.
|
Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.
|
|
ACTIVE_COMPARATOR: Control group
The control group will receive standard care plus a smartphone for 12 months; they will provide study outcome data monthly for the next 12 months.
|
Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Asthma control test (ACT®) scores.
Time Frame: One year.
|
One year.
|
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Asthma-related healthcare utilization.
Time Frame: One year.
|
One year.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
School absenteeism.
Time Frame: One year.
|
One year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
October 8, 2009
First Submitted That Met QC Criteria
October 9, 2009
First Posted (ESTIMATE)
October 12, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 3, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-2008-1234
- 5R01NR010241 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.