Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Arkansas Children's Hospital Research Institute
Sponsor:
Collaborators:
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01167855
First received: July 21, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Asthma
Quality of Life
Children
Health Disparities
Telemedicine Education
Other: Asthma Education Sessions
Other: Asthma Health Assessment via Telemonitoring
Other: Provider Treatment Prompt
Other: School Absenteeism
Other: Prescription Filling Profile

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Symptom Free Days [ Time Frame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention. ] [ Designated as safety issue: No ]
    Examine the efficacy of a school-based asthma telemedicine intervention.


Secondary Outcome Measures:
  • Secondary Clinical Outcomes [ Time Frame: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up. ] [ Designated as safety issue: No ]
    Secondary clinical outcomes will be measured at specific time points during the intervention.


Estimated Enrollment: 1110
Study Start Date: March 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
  • Telemedicine asthma education sessions
  • Asthma health assessment via telemonitoring
  • Provider treatment prompts
  • School absenteeism
  • Prescription filling profile
Other: Asthma Education Sessions
Comprehensive asthma education sessions delivered via telemedicine.
Other: Asthma Health Assessment via Telemonitoring
Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.
Other: Provider Treatment Prompt
A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
Other: School Absenteeism
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.
Other: Prescription Filling Profile
Study personnel will monitor participants' prescription profiles.

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

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01167855

Contacts
Contact: Rita C Hudson Brown, BA 501-364-1538 ext 41538 brownritac@uams.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Rita C Hudson Brown, BA    501-364-1538 ext 41538    brownritac@uams.edu   
Contact: C         
Principal Investigator: Tamara T. Perry, M.D.         
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:
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01167855     History of Changes
Other Study ID Numbers: 112695, 1R01HL102388 -01
Study First Received: July 21, 2010
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Arkansas Children's Hospital Research Institute:
Pediatric Asthma
Low-income
Arkansas Delta Region

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 August 28, 2014