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Completed

NCT Number: NCT01167855

Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

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.

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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Asthma Education Sessions

Other

Comprehensive asthma education sessions delivered via telemedicine.

Asthma Health Assessment via Telemonitoring

Other

Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.

Provider Treatment Prompt

Other

A treatment prompt will be mailed to the primary care provider at baseline and 3 months.

School Absenteeism

Other

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.

Prescription Filling Profile

Other

Study personnel will monitor participants' prescription profiles.

Primary outcomes

  1. Symptom Free Days

    Time frame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.

    Examine the efficacy of a school-based asthma telemedicine intervention.

Secondary outcomes

  1. Secondary Clinical Outcomes

    Time frame: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.

    Secondary clinical outcomes will be measured at specific time points during the intervention.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Arkansas

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jul 22, 2010
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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