Clinical trial NCT00964301: Telemedicine Education for Rural Children With Asthma
Official title: Telemedicine Education for Rural Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Low-income
Quality of life
Children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2009-08-24
Enrollment: 106
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group.
timeFrame: One year
Secondary outcomes:
measure: 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.
timeFrame: One year
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Tamara T. Perry, M.D., FAAP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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
citation: Dey AN, Schiller JS, Tai DA. Summary health statistics for U.S. children: National Health Interview Survey, 2002. Vital Health Stat 10. 2004 Mar;(221):1-78.
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. doi: 10.1001/archpedi.1990.02150350021016.
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. doi: 10.1542/peds.111.5.1046.
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. doi: 10.1016/j.jaci.2003.09.037.
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. doi: 10.1016/j.jaci.2004.05.025.
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. doi: 10.1016/S1081-1206(10)61340-3.
citation: Nash C, Ochoa ER. Arkansas Racial and Ethnic Health Disparity Study Report. Little Rock, AR: Arkansas Minority Health Commission, 2004.
citation: National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart Lung and Blood Insitutute. 2007.
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. doi: 10.1080/02770900500369850.
citation: 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. doi: 10.3109/02770909909065155.