Status:
COMPLETED
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Arkansas
Conditions:
Asthma
Quality of Life
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief Summary
The overall goal of this proposal is to examine the efficacy of a school-based asthma telemedicine intervention in a predominately minority, low-income rural pediatric population.
Detailed Description
A total of 1110 subjects will be enrolled in this research study. Five hundred forty (540) subjects will be between the ages of 7-14 years. The remaining 540 subjects will be comprised of the primary ...
Eligibility Criteria
Inclusion
- The investigators will recruit students (ages 7-14 years) with asthma who are currently enrolled in public school districts located in the Delta region of Arkansas.
- Eligibility of identified children will be determined by a brief telephone survey. The survey questions will determine if the child fulfills inclusion/exclusion criteria.
- Age ≥ 7 and ≤ 14 years.
- Use of asthma medications for acute relief of symptoms (rescue) or for control of symptoms (preventive) in the past 6 months. Children not on a controller who report using a rescue medication only for prevention of exercised-induced symptoms will not be eligible for the study.
- Physician-diagnosed asthma by parent/caregiver report. OR
- In the absence of a formal physician diagnosis, the caregiver must report symptoms consistent with at least mild persistent asthma. The investigators will use asthma screening criteria to ensure that participants meet eligibility requirements. Participants must establish a history of episodic airflow obstruction or airway hyperresponsiveness and meet National Heart Lung and Blood Institute (NHLBI) guidelines for persistent asthma. Mild persistent asthma will be defined as any 1 of the following during the prior 4 weeks (by caregiver report):
- An average of \> 2 days per week with asthma symptoms
- \> 2 days per week with rescue medication use
- \> 2 nights per month awakened with nighttime symptoms
- Minor limitation of activity
- ≥ 2 episodes of asthma during the past year that have required systemic corticosteroids
Exclusion
- Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
- Significant co-morbid conditions (such as severe developmental delay) that could preclude participation in an education-based intervention.
- Inability to speak or understand English (child or parent).
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
- Families without access to a working telephone as all survey data will be collected via telephone.
Key Trial Info
Start Date :
May 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
823 Patients enrolled
Trial Details
Trial ID
NCT01167855
Start Date
May 25 2011
End Date
February 1 2017
Last Update
May 16 2017
Active Locations (1)
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1
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202