NCT00214383

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable asthma

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

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 9, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Results QC Date

April 4, 2012

Last Update Submit

January 16, 2013

Conditions

Asthma

Keywords

pediatric asthma

Outcome Measures

Primary Outcomes (2)

  • Percentage Changed in Adherence Score

    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.

    Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores

  • Number of Symptom-free Days

    A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.

    Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores

Secondary Outcomes (1)

  • Improvement in Asthma Control

    Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores

Study Arms (2)

CHESS + Case Mgt

EXPERIMENTAL

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

Control

NO INTERVENTION

Control-usual care. Usual care refers to the manner in which clients generally manage their asthma.

Interventions

CHESS Internet telehealthBEHAVIORAL

CHESS Internet telehealth

CHESS + Case Mgt

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children, aged 4-12 with moderate to severe asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wise M, Gustafson DH, Sorkness CA, Molfenter T, Staresinic A, Meis T, Hawkins RP, Shanovich KK, Walker NP. Internet telehealth for pediatric asthma case management: integrating computerized and case manager features for tailoring a Web-based asthma education program. Health Promot Pract. 2007 Jul;8(3):282-91. doi: 10.1177/1524839906289983. Epub 2006 Aug 23.

    PMID: 16928987BACKGROUND

  • Wise M, Pulvermacher A, Shanovich KK, Gustafson DH, Sorkness C, Bhattacharya A. Using action research to implement an integrated pediatric asthma case management and eHealth intervention for low-income families. Health Promot Pract. 2010 Nov;11(6):798-806. doi: 10.1177/1524839909334621. Epub 2009 Jun 10.

    PMID: 19515862RESULT

  • Gustafson D, Wise M, Bhattacharya A, Pulvermacher A, Shanovich K, Phillips B, Lehman E, Chinchilli V, Hawkins R, Kim JS. The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial. J Med Internet Res. 2012 Jul 26;14(4):e101. doi: 10.2196/jmir.1964.

    PMID: 22835804RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Alice Pulvermacher
Organization
University of Wisconsin - Madison
alice.pulvermacher@chess.wisc.edu
(608) 262-8448

Study Officials

  • David Gustafson, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2004

Primary Completion

August 1, 2007

Study Completion

May 1, 2009

Last Updated

January 24, 2013

Results First Posted

July 9, 2012

Record last verified: 2013-01