Internet Telehealth for Pediatric Asthma Case Management

Asthma Clinical Trial

— CHESS  

Official title:

Internet Telehealth for Pediatric Asthma Case Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214383
• Other study ID #: 2002-163
• Secondary ID: 5R01NR007889-02
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 16, 2013
• Start date: May 2004
• Est. completion date: May 2009

Study information

• Verified date: January 2013
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: May 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• CHESS Internet telehealth
CHESS Internet telehealth

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

References & Publications (3)

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 — View Citation

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. Epub 2006 Aug 23. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Improvement in Asthma Control	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.	Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores	No