Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

NCT01167855 | Completed DMC

• 2 other identifiers: 1126951R01HL102388-01
• Study Type: interventional
• Target: 823
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Quality of Life; Children

Keywords

Pediatric Asthma; Low-income; Arkansas Delta Region

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Clinical Outcomes

  Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.

Study Arms (1)

Intervention

EXPERIMENTAL

* Telemedicine asthma education sessions * Asthma health assessment via telemonitoring * Provider treatment prompts * School absenteeism * Prescription filling profile

Other: Asthma Education Sessions; Other: Asthma Health Assessment via Telemonitoring; Other: Provider Treatment Prompt; Other: School Absenteeism; Other: Prescription Filling Profile

Interventions

Asthma Education Sessions OTHER

Comprehensive asthma education sessions delivered via telemedicine.

Intervention

Asthma Health Assessment via Telemonitoring OTHER

Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.

Intervention

Provider Treatment Prompt OTHER

A treatment prompt will be mailed to the primary care provider at baseline and 3 months.

Intervention

School Absenteeism OTHER

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.

Intervention

Prescription Filling Profile OTHER

Study personnel will monitor participants' prescription profiles.

Intervention

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Age ≥ 7 and ≤ 14 years.
• 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.
• Physician-diagnosed asthma by parent/caregiver report. OR
• 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
• Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
• Significant co-morbid conditions (such as severe developmental delay) that could preclude participation in an education-based intervention.
• Inability to speak or understand English (child or parent).
• Children in foster care or other situations in which consent cannot be obtained from a guardian.
• Prior enrollment in the study.
• Families without access to a working telephone as all survey data will be collected via telephone.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Arkansas: collaborator

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (5)

• 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.

  PMID: 18939725 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15356547 BACKGROUND

• 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.

  PMID: 12135408 BACKGROUND

• 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.

  PMID: 29471032 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tamara T. Perry, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: May 25, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)