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Little Rock, Arkansas 72202


Purpose:

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.


Study summary:

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 caregiver of the participants. Thirty (30) school nurse/s providing care to the 270 intervention participants will also be enrolled in the study. To test our hypotheses, the investigators will conduct a cluster randomized trial with 540 children, ages 7-14 years and their parent/guardian(s), to address the following specific aims: Specific Aim 1: Examine the efficacy of a school-based asthma telemedicine intervention in improving asthma-related health outcomes in an intervention group compared to children receiving usual care. Specific Aim 2: Determine the effects of a school-based asthma telemedicine intervention on asthma self-management skills of intervention caregivers and participants compared to a usual care group. The investigators will compare changes in asthma self-efficacy, quality of life, and knowledge between groups. Specific Aim 3: Determine the cost of the intervention in relation to health outcomes.


Criteria:

Inclusion Criteria: 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. 1. Age ≥ 7 and ≤ 14 years. 2. 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. 3. Physician-diagnosed asthma by parent/caregiver report. OR 4. 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 Criteria: 1. Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures. 2. Significant co-morbid conditions (such as severe developmental delay) that could preclude participation in an education-based intervention. 3. Inability to speak or understand English (child or parent). 4. Children in foster care or other situations in which consent cannot be obtained from a guardian. 5. Prior enrollment in the study. 6. Families without access to a working telephone as all survey data will be collected via telephone.


NCT ID:

NCT01167855


Primary Contact:

Principal Investigator
Tamara T. Perry, M.D.
University of Arkansas


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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