View Clinical Trial (Medical Research Study)
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
| City: |
|
Little Rock |
| State: |
|
Arkansas |
| Zip Code: |
|
72202 |
| Conditions: |
|
Asthma - Quality of Life - Children - Health Disparities - Telemedicine Education |
| Purpose: |
|
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 Summary: |
|
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.
|
| Criteria: |
|
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 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.
|
| NCT ID: |
|
NCT01167855 |
| Primary Contact: |
|
Principal Investigator
Tamara T. Perry, M.D.
University of Arkansas
Rita C Hudson Brown, BA
Phone: 501-364-1538 ext. 41538
Email: brownritac@uams.edu
|
| Backup Contact: |
|
Email: broberts@uams.edu
Brandi L Roberts, MPH
Phone: 501-364-3641 ext. 43641
|
| Location Contact: |
|
Little Rock, Arkansas 72202
United States
Brandi L Roberts, BS
Phone: 501-364-3641
Email: broberts@uams.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|