NCT00993590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

October 8, 2009

Last Update Submit

February 3, 2016

Conditions

Asthma

Keywords

Persistent asthmaAsthma related emergency room visitsAsthma control, adolescentsAdherence, asthma control medications

Outcome Measures

Primary Outcomes (2)

  • Asthma control test (ACT®) scores.

    One year.

  • Asthma-related healthcare utilization.

    One year.

Secondary Outcomes (1)

  • School absenteeism.

    One year.

Study Arms (2)

M CHESS group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

M CHESSBEHAVIORAL

Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.

Control groupM CHESS group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Other chronic pulmonary disorders such as cystic fibrosis, ABPA, or bronchopulmonary dysplasia.
  • Developmental/cognitive/sensory disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Managed Health Services

Milwaukee, Wisconsin, 53214, United States

Location

United Healthcare

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 12, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

US(2)