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

Status

Completed

Conditions

Intervention / Treatment

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

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53214
        • Managed Health Services
      • Milwaukee, Wisconsin, United States, 53226
        • United Healthcare

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.
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.

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

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.

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