search
Back to results

Mobile CHESS Research on Emergency Medical Services for Children

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M CHESS
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Persistent asthma, Asthma related emergency room visits, Asthma control, adolescents, Adherence, asthma control medications

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Managed Health Services
  • United Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M CHESS group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Asthma control test (ACT®) scores.
Asthma-related healthcare utilization.

Secondary Outcome Measures

School absenteeism.

Full Information

First Posted
October 8, 2009
Last Updated
February 3, 2016
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00993590
Brief Title
Mobile CHESS Research on Emergency Medical Services for Children
Official Title
Mobile CHESS Research on Emergency Medical Services for Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Persistent asthma, Asthma related emergency room visits, Asthma control, adolescents, Adherence, asthma control medications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M CHESS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
M CHESS
Intervention Description
Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.
Primary Outcome Measure Information:
Title
Asthma control test (ACT®) scores.
Time Frame
One year.
Title
Asthma-related healthcare utilization.
Time Frame
One year.
Secondary Outcome Measure Information:
Title
School absenteeism.
Time Frame
One year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Managed Health Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53214
Country
United States
Facility Name
United Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile CHESS Research on Emergency Medical Services for Children

We'll reach out to this number within 24 hrs