Mobile CHESS Research on Emergency Medical Services for Children

This study has been terminated.
(Recruitment halted as research group determined that they had sufficient numbers to determine if the intervention had an effect.)
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00993590
First received: October 8, 2009
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Asthma
Behavioral: M CHESS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mobile CHESS Research on Emergency Medical Services for Children

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Asthma control test (ACT®) scores. [ Time Frame: One year. ] [ Designated as safety issue: No ]
  • Asthma-related healthcare utilization. [ Time Frame: One year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • School absenteeism. [ Time Frame: One year. ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: M CHESS
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.
Behavioral: M CHESS
Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993590

Locations
United States, Wisconsin
United Healthcare
Milwaukee, Wisconsin, United States, 53226
Managed Health Services
Milwaukee, Wisconsin, United States, 53214
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: David H. Gustafson, PhD, Center for Health Enhancement Systems Studies (CHESS)
ClinicalTrials.gov Identifier: NCT00993590     History of Changes
Other Study ID Numbers: 5 R01 NR010241
Study First Received: October 8, 2009
Last Updated: December 23, 2009
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Persistent asthma
Asthma related emergency room visits
Asthma control, adolescents
Adherence, asthma control medications

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014