An interventional study of Asthma Education Sessions and Asthma Health Assessment via Telemonitoring in Asthma, Quality of Life and Children, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Health services research
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 823 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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):
Exclusion Criteria:
* Telemedicine asthma education sessions * Asthma health assessment via telemonitoring * Provider treatment prompts * School absenteeism * Prescription filling profile
Other: Asthma Education Sessions · Other: Asthma Health Assessment via Telemonitoring · Other: Provider Treatment Prompt · Other: School Absenteeism · Other: Prescription Filling Profile
Comprehensive asthma education sessions delivered via telemedicine.
Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.
A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
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.
Study personnel will monitor participants' prescription profiles.
Symptom Free Days
Examine the efficacy of a school-based asthma telemedicine intervention.
Time frame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Secondary Clinical Outcomes
Secondary clinical outcomes will be measured at specific time points during the intervention.
Time frame: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.
Plan to share: No — There is no plan to share individual participant data.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Arkansas Children's Hospital Research Institute