Clinical trial NCT01167855: Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Official title: Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Quality of Life
Children
Keywords: Pediatric Asthma
Low-income
Arkansas Delta Region
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Arkansas
First posted: 2010-07-22
Enrollment: 823
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility 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 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.

Primary outcomes:
measure: Symptom Free Days
timeFrame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Secondary outcomes:
measure: Secondary Clinical Outcomes
timeFrame: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Tamara T. Perry, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/j.jaci.2004.05.025.
citation: Tilford JM. Cost-effectiveness analysis and emergency medical services for children: issues and applications. Ambul Pediatr. 2002 Jul-Aug;2(4 Suppl):330-6. doi: 10.1367/1539-4409(2002)0022.0.co;2.
citation: Perry TT, Halterman JS, Brown RH, Luo C, Randle SM, Hunter CR, Rettiganti M. Results of an asthma education program delivered via telemedicine in rural schools. Ann Allergy Asthma Immunol. 2018 Apr;120(4):401-408. doi: 10.1016/j.anai.2018.02.013. Epub 2018 Feb 19.