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Telemedicine Education for Rural Children With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Education
Usual care
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Low-income, Quality of life, Children

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arkansas Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Usual care

Arm Description

Participants, caregivers and school nurse will attend telemedicine education sessions at school.

Usual care participant will receive routine care from their primary care provider.

Outcomes

Primary Outcome Measures

The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group.

Secondary Outcome Measures

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.

Full Information

First Posted
August 20, 2009
Last Updated
September 11, 2017
Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00964301
Brief Title
Telemedicine Education for Rural Children With Asthma
Official Title
Telemedicine Education for Rural Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Low-income, Quality of life, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants, caregivers and school nurse will attend telemedicine education sessions at school.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care participant will receive routine care from their primary care provider.
Intervention Type
Other
Intervention Name(s)
Telemedicine Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.
Primary Outcome Measure Information:
Title
The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group.
Time Frame
One year
Secondary Outcome Measure Information:
Title
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara T. Perry, M.D., FAAP
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
18939725
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.
Results Reference
background
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
Results Reference
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PubMed Identifier
15791897
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.
Results Reference
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PubMed Identifier
2239856
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.
Results Reference
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PubMed Identifier
12728087
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.
Results Reference
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PubMed Identifier
14713909
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. Erratum In: J Allergy Clin Immunol. 2004 Mar;113(3):391.
Results Reference
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PubMed Identifier
15356547
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.
Results Reference
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PubMed Identifier
16802765
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.
Results Reference
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Citation
Nash C, Ochoa ER. Arkansas Racial and Ethnic Health Disparity Study Report. Little Rock, AR: Arkansas Minority Health Commission, 2004.
Results Reference
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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.
Results Reference
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PubMed Identifier
16393717
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.
Results Reference
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PubMed Identifier
10077141
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. Erratum In: J Asthma. 2011 May;48(4):427.
Results Reference
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Telemedicine Education for Rural Children With Asthma

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