NCT00964301

Brief Summary

The investigators will implement an interactive school-based telemedicine education program for rural low-income, minority children with asthma, their caregivers, and school nurses in the Delta region of Arkansas. Specific aims:

  1. 1.The investigators will examine changes in asthma symptoms control and other health outcomes such as activity levels and family/child emotional health in the intervention group compared to a usual care group.
  2. 2.The investigators will examine changes in asthma knowledge, self-efficacy, and quality of life in the intervention participants and their caregivers compared to a usual care group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

2.9 years

First QC Date

August 20, 2009

Last Update Submit

September 11, 2017

Conditions

Keywords

AsthmaLow-incomeQuality of lifeChildren

Outcome Measures

Primary Outcomes (1)

  • The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group.

    One year

Secondary Outcomes (1)

  • The investigators will examine changes in asthma knowledge, self-efficacy, and quality of life of the intervention participants and their caregivers compared to a usual care group.

    One year

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants, caregivers and school nurse will attend telemedicine education sessions at school.

Other: Telemedicine Education

Usual care

ACTIVE COMPARATOR

Usual care participant will receive routine care from their primary care provider.

Other: Usual care

Interventions

Student Asthma Education. Each student will engage in 6 age-appropriate sessions on various aspects of asthma health. Caregiver Asthma Education. The primary caregiver will engage in 2 asthma education sessions. School Nurse Asthma Education. School nurses will participate in 2 sessions. Primary Care Provider (PCP) Communication. The PCP of the intervention group participant will be notified of his/her patient's baseline asthma assessment. They will receive updates summarizing each telemedicine intervention.

Intervention Group

Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.

Usual care

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Study participants will be English-speaking children ages 7-17 years with physician-diagnosed asthma and/or active symptoms in the previous 12 months.
  • Active symptoms include one or more of the following:
  • experience daytime wheezing, shortness of breath, and/or coughing two or more times a week for the last 4 weeks;
  • nighttime wheezing, shortness of breath and/or cough more than once a week;
  • take asthma medication more than two days a week;
  • have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms;
  • have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms have episodes of asthma-like symptoms when playing/exercising.
  • Potentially eligible participants will be screened using an asthma screener to confirm eligibility.

You may not qualify if:

  • Children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions (such as severe developmental delay or cerebral palsy) will be excluded from the study.
  • The primary caregiver and child will be asked questions via telephone interview about how asthma affects the child every day. Children with no telephone number or contact telephone number will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (12)

  • 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: 18939725BACKGROUND
  • Perry TT, Vargas PA, Brown RH et al. Asthma morbidity in high risk rural children in the delta region of Arkansas. J Allergy Clin Immunol. 2008;121:S231

    BACKGROUND
  • Dey AN, Schiller JS, Tai DA. Summary health statistics for U.S. children: National Health Interview Survey, 2002. Vital Health Stat 10. 2004 Mar;(221):1-78.

    PMID: 15791897BACKGROUND
  • Weitzman M, Gortmaker S, Sobol A. Racial, social, and environmental risks for childhood asthma. Am J Dis Child. 1990 Nov;144(11):1189-94. doi: 10.1001/archpedi.1990.02150350021016.

    PMID: 2239856BACKGROUND
  • Yeatts K, Davis KJ, Sotir M, Herget C, Shy C. Who gets diagnosed with asthma? Frequent wheeze among adolescents with and without a diagnosis of asthma. Pediatrics. 2003 May;111(5 Pt 1):1046-54. doi: 10.1542/peds.111.5.1046.

    PMID: 12728087BACKGROUND
  • Chrischilles E, Ahrens R, Kuehl A, Kelly K, Thorne P, Burmeister L, Merchant J. Asthma prevalence and morbidity among rural Iowa schoolchildren. J Allergy Clin Immunol. 2004 Jan;113(1):66-71. doi: 10.1016/j.jaci.2003.09.037.

    PMID: 14713909BACKGROUND
  • 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: 15356547BACKGROUND
  • Vargas PA, Simpson PM, Bushmiaer M, Goel R, Jones CA, Magee JS, Feild CR, Jones SM. Symptom profile and asthma control in school-aged children. Ann Allergy Asthma Immunol. 2006 Jun;96(6):787-93. doi: 10.1016/S1081-1206(10)61340-3.

    PMID: 16802765BACKGROUND
  • Nash C, Ochoa ER. Arkansas Racial and Ethnic Health Disparity Study Report. Little Rock, AR: Arkansas Minority Health Commission, 2004.

    BACKGROUND
  • National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart Lung and Blood Insitutute. 2007.

    BACKGROUND
  • Butz A, Pham L, Lewis L, Lewis C, Hill K, Walker J, Winkelstein M. Rural children with asthma: impact of a parent and child asthma education program. J Asthma. 2005 Dec;42(10):813-21. doi: 10.1080/02770900500369850.

    PMID: 16393717BACKGROUND
  • Bursch B, Schwankovsky L, Gilbert J, Zeiger R. Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma. 1999;36(1):115-28. doi: 10.3109/02770909909065155.

    PMID: 10077141BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tamara T. Perry, M.D., FAAP

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 24, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2012

Study Completion

March 1, 2015

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations