Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Conditions
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Asthma, Quality of Life, Children

Intervention / Treatment
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* Other: Asthma Education Sessions
* Other: Asthma Health Assessment via Telemonitoring
* Other: Provider Treatment Prompt
* Other: School Absenteeism
* Other: Prescription Filling Profile


Participation Criteria
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Eligibility Criteria
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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. 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Telemedicine asthma education sessions Asthma health assessment via telemonitoring Provider treatment prompts School absenteeism Prescription filling profile | Other: Asthma Education Sessions<br>* Comprehensive asthma education sessions delivered via telemedicine.<br>Other: Asthma Health Assessment via Telemonitoring<br>* Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.<br>Other: Provider Treatment Prompt<br>* A treatment prompt will be mailed to the primary care provider at baseline and 3 months.<br>Other: School Absenteeism<br>* Absenteeism before and after the intervention will be compared in the intervention group and also will be compared to absentee rates of the usual care group.<br>Other: Prescription Filling Profile<br>* Study personnel will monitor participants' prescription profiles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Free Days | Examine the efficacy of a school-based asthma telemedicine intervention. | The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Clinical Outcomes | Secondary clinical outcomes will be measured at specific time points during the intervention. | Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Asthma, Low-income, Arkansas Delta Region