Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
NCT Number: NCT01167855
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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Notify Me7 year–14 year
All sexes
Interventional
Not applicable
Little Rock, Arkansas, 72202, United States
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.
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.
Exclusion criteria
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.
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.
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.
Arkansas Children's Hospital Research Institute
Other
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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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