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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00964301
Other study ID # 110807
Secondary ID
Status Completed
Phase N/A
First received August 20, 2009
Last updated September 11, 2017
Start date August 2009
Est. completion date March 2015

Study information

Verified date September 2017
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will implement an interactive school-based telemedicine education program for rural low-income, minority children with asthma, their caregivers, and school nurses in the Delta region of Arkansas.

Specific aims:

1. The investigators will examine changes in asthma symptoms control and other health outcomes such as activity levels and family/child emotional health in the intervention group compared to a usual care group.

2. The investigators will examine changes in asthma knowledge, self-efficacy, and quality of life in the intervention participants and their caregivers compared to a usual care group.


Description:

The investigators will conduct a prospective study to examine the impact of an interactive, telemedicine asthma intervention among children living in the rural Delta region of Arkansas.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date March 2015
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria:

- Study participants will be English-speaking children ages 7-17 years with physician-diagnosed asthma and/or active symptoms in the previous 12 months.

- Active symptoms include one or more of the following:

- experience daytime wheezing, shortness of breath, and/or coughing two or more times a week for the last 4 weeks;

- nighttime wheezing, shortness of breath and/or cough more than once a week;

- take asthma medication more than two days a week;

- have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms;

- have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms have episodes of asthma-like symptoms when playing/exercising.

- Potentially eligible participants will be screened using an asthma screener to confirm eligibility.

Exclusion Criteria:

- Children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions (such as severe developmental delay or cerebral palsy) will be excluded from the study.

- The primary caregiver and child will be asked questions via telephone interview about how asthma affects the child every day. Children with no telephone number or contact telephone number will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telemedicine Education
Student Asthma Education. Each student will engage in 6 age-appropriate sessions on various aspects of asthma health. Caregiver Asthma Education. The primary caregiver will engage in 2 asthma education sessions. School Nurse Asthma Education. School nurses will participate in 2 sessions. Primary Care Provider (PCP) Communication. The PCP of the intervention group participant will be notified of his/her patient's baseline asthma assessment. They will receive updates summarizing each telemedicine intervention.
Usual care
Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.

Locations

Country Name City State
United States Arkansas Children's Hospital Research Institute Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bursch B, Schwankovsky L, Gilbert J, Zeiger R. Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma. 1999;36(1):115-28. Erratum in: J Asthma. 2011 May;48(4):427. — View Citation

Butz A, Pham L, Lewis L, Lewis C, Hill K, Walker J, Winkelstein M. Rural children with asthma: impact of a parent and child asthma education program. J Asthma. 2005 Dec;42(10):813-21. — View Citation

Chrischilles E, Ahrens R, Kuehl A, Kelly K, Thorne P, Burmeister L, Merchant J. Asthma prevalence and morbidity among rural Iowa schoolchildren. J Allergy Clin Immunol. 2004 Jan;113(1):66-71. Erratum in: J Allergy Clin Immunol. 2004 Mar;113(3):391. — View Citation

Dey AN SJ, Tai DA. Summary Health Statistics for U.S. Children: National Health Interview Survey, 2002. National Center for Health Statistics. Vital Health Stat. 2004;10(221).

Nash C, Ochoa ER. Arkansas Racial and Ethnic Health Disparity Study Report. Little Rock, AR: Arkansas Minority Health Commission, 2004.

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330. — View Citation

Perry TT, Vargas PA, Brown RH et al. Asthma morbidity in high risk rural children in the delta region of Arkansas. J Allergy Clin Immunol. 2008;121:S231

Perry TT, Vargas PA, McCracken A, Jones SM. Underdiagnosed and uncontrolled asthma: findings in rural schoolchildren from the Delta region of Arkansas. Ann Allergy Asthma Immunol. 2008 Oct;101(4):375-81. doi: 10.1016/S1081-1206(10)60313-4. — View Citation

Vargas PA, Simpson PM, Bushmiaer M, Goel R, Jones CA, Magee JS, Feild CR, Jones SM. Symptom profile and asthma control in school-aged children. Ann Allergy Asthma Immunol. 2006 Jun;96(6):787-93. — View Citation

Vargas PA, Simpson PM, Gary Wheeler J, Goel R, Feild CR, Tilford JM, Jones SM. Characteristics of children with asthma who are enrolled in a Head Start program. J Allergy Clin Immunol. 2004 Sep;114(3):499-504. — View Citation

Weitzman M, Gortmaker S, Sobol A. Racial, social, and environmental risks for childhood asthma. Am J Dis Child. 1990 Nov;144(11):1189-94. — View Citation

Yeatts K, Davis KJ, Sotir M, Herget C, Shy C. Who gets diagnosed with asthma? Frequent wheeze among adolescents with and without a diagnosis of asthma. Pediatrics. 2003 May;111(5 Pt 1):1046-54. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group. One year
Secondary The investigators will examine changes in asthma knowledge, self-efficacy, and quality of life of the intervention participants and their caregivers compared to a usual care group. One year
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