Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
|ClinicalTrials.gov Identifier: NCT01167855|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma Quality of Life Children||Other: Asthma Education Sessions Other: Asthma Health Assessment via Telemonitoring Other: Provider Treatment Prompt Other: School Absenteeism Other: Prescription Filling Profile||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||823 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children|
|Actual Study Start Date :||May 25, 2011|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||February 1, 2017|
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.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167855
|United States, Arkansas|
|Arkansas Children's Hospital Research Institute|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Tamara T. Perry, M.D.||University of Arkansas|