Telemedicine Education for Rural Children With Asthma

NCT ID: NCT00964301

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. 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. 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will conduct a prospective study to examine the impact of an interactive, telemedicine asthma intervention among children living in the rural Delta region of Arkansas.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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

Group Type EXPERIMENTAL

Telemedicine Education

Intervention Type OTHER

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.

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telemedicine Education

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 Type OTHER

Usual care

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arkansas

OTHER

Sponsor Role collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tamara T. Perry, M.D., FAAP

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18939725 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 15791897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2239856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12728087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14713909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15356547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16802765 (View on PubMed)

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16393717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10077141 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110807

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self Management Education Asthma
NCT00005712 TERMINATED
Telecommunications System in Asthma
NCT00232557 COMPLETED PHASE3
Rural Asthma Effectiveness Study
NCT03533764 COMPLETED NA