Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

May 15, 2017 updated by: Arkansas Children's Hospital Research Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

823

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2011

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (ESTIMATE)

July 22, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112695
  • 1R01HL102388-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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