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Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01167855
Enrollment
823
Registered
2010-07-22
Start date
2011-05-25
Completion date
2017-02-01
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Children, Quality of Life

Keywords

Pediatric Asthma, Low-income, Arkansas Delta Region

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 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.

Interventions

OTHERAsthma Education Sessions

Comprehensive asthma education sessions delivered via telemedicine.

OTHERAsthma 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.

OTHERProvider Treatment Prompt

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

OTHERSchool 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.

OTHERPrescription Filling Profile

Study personnel will monitor participants' prescription profiles.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Arkansas
CollaboratorOTHER
Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom Free DaysThe 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

MeasureTime frameDescription
Secondary Clinical OutcomesSecondary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026