Telemedicine Education for Rural Children With Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00964301
First received: August 20, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention
Asthma
Other: Telemedicine Education
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedicine Education for Rural Children With Asthma

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • The investigators will examine changes in asthma symptoms control and health outcomes in the intervention group compared to a usual care group. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
Participants, caregivers and school nurse will attend telemedicine education sessions at school.
Other: 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.

Active Comparator: Usual care Other: Usual care
Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964301

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
Investigators
Principal Investigator: Tamara T. Perry, M.D. University of Arkansas
  More Information

Publications:
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

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00964301     History of Changes
Other Study ID Numbers: 110807
Study First Received: August 20, 2009
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Asthma
Low-income
Quality of life
Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014