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Internet Telehealth for Pediatric Asthma Case Management (CHESS)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214383
First received: September 13, 2005
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

The original and primary aim of this study is to evaluate the effects of CHESS with Nurse Case Management on asthma control (symptom-free days), and adherence factors of children aged 4-12. The investigators have expanded the scope of the specific aims. The criteria for their expanded aim is to also interview low-income African-American caregivers to gain an understanding of how they conceptualize their child's asthma, and what they consider to be barriers or facilitators to managing their child's asthma. There is no change in the investigators' original aim.


Condition Intervention
Asthma
 Behavioral: CHESS Internet telehealth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet Telehealth for Pediatric Asthma Case Management

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Percentage Changed in Adherence Score [ Time Frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores ] [ Designated as safety issue: No ]
    A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.

  • Number of Symptom-free Days [ Time Frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores ] [ Designated as safety issue: No ]
    A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.


Secondary Outcome Measures:
  • Improvement in Asthma Control [ Time Frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores ] [ Designated as safety issue: No ]
    A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.


Enrollment: 301
Study Start Date: May 2004
Study Completion Date: May 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHESS + Case Mgt
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. Support calls refer to check in calls by a nurse to the parents to see how the child is doing. CHESS services include access to a website with information on asthma management, discussion groups and a case manager. The website also include a management tool for asthma symptoms check in, and the case manager used the information entered to tailor the homepage to individual clients.
 Behavioral: CHESS Internet telehealth
CHESS Internet telehealth
No Intervention: Control
Control-usual care. Usual care refers to the manner in which clients generally manage their asthma.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents of children, aged 4-12 with moderate to severe asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214383

Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Investigators
Principal Investigator: David Gustafson, PhD University of Wisconsin, Madison
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214383     History of Changes
Other Study ID Numbers: 2002-163, 5R01 NR007889-02
Study First Received: September 13, 2005
Results First Received: April 4, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
pediatric asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013