Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Asthma Clinical Trial

Official title:

Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167855
• Other study ID #: 112695
• Secondary ID: 1R01HL102388-01
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: May 15, 2017
• Start date: May 25, 2011
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Asthma
• Children
• Quality of Life

Intervention

Other:
• Asthma Education Sessions
Comprehensive asthma education sessions delivered via telemedicine.
• 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.
• Provider Treatment Prompt
A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
• 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.
• Prescription Filling Profile
Study personnel will monitor participants' prescription profiles.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	National Heart, Lung, and Blood Institute (NHLBI), University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (5)

Perry TT, Vargas PA, Brown R, Watkins D, McCracken A, Jones S. Asthma morbidity in high risk rural children in the delta region of Arkansas. J Allergy Clin Immunol 2008;121:S231.

Perry TT, Vargas PA, McCracken A, Jones SM. Underdiagnosed and uncontrolled asthma: findings in rural schoolchildren from the Delta region of Arkansas. Ann Allergy Asthma Immunol. 2008 Oct;101(4):375-81. doi: 10.1016/S1081-1206(10)60313-4. — View Citation

Pesek R, PA V, Jones S, McCracken A, Perry TT. Pediatric asthma diagnosis and morbidity in urban and rural Arkansas. J Allergy Clin Immunol 2009;123:S210.

Tilford JM. Cost-effectiveness analysis and emergency medical services for children: issues and applications. Ambul Pediatr. 2002 Jul-Aug;2(4 Suppl):330-6. — View Citation

Vargas PA, Simpson PM, Gary Wheeler J, Goel R, Feild CR, Tilford JM, Jones SM. Characteristics of children with asthma who are enrolled in a Head Start program. J Allergy Clin Immunol. 2004 Sep;114(3):499-504. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Free Days	Examine the efficacy of a school-based asthma telemedicine intervention.	The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Secondary	Secondary Clinical Outcomes	Secondary clinical outcomes will be measured at specific time points during the intervention.	Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.