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Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

Primary Purpose

Asthma, Quality of Life, Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Education Sessions
Asthma Health Assessment via Telemonitoring
Provider Treatment Prompt
School Absenteeism
Prescription Filling Profile
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Pediatric Asthma, Low-income, Arkansas Delta Region

Eligibility Criteria

7 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arkansas Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Symptom Free Days
Examine the efficacy of a school-based asthma telemedicine intervention.

Secondary Outcome Measures

Secondary Clinical Outcomes
Secondary clinical outcomes will be measured at specific time points during the intervention.

Full Information

First Posted
July 21, 2010
Last Updated
May 15, 2017
Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT01167855
Brief Title
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Official Title
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 25, 2011 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Quality of Life, Children
Keywords
Pediatric Asthma, Low-income, Arkansas Delta Region

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
823 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Telemedicine asthma education sessions Asthma health assessment via telemonitoring Provider treatment prompts School absenteeism Prescription filling profile
Intervention Type
Other
Intervention Name(s)
Asthma Education Sessions
Intervention Description
Comprehensive asthma education sessions delivered via telemedicine.
Intervention Type
Other
Intervention Name(s)
Asthma Health Assessment via Telemonitoring
Intervention Description
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 Type
Other
Intervention Name(s)
Provider Treatment Prompt
Intervention Description
A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
Intervention Type
Other
Intervention Name(s)
School Absenteeism
Intervention Description
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 Type
Other
Intervention Name(s)
Prescription Filling Profile
Intervention Description
Study personnel will monitor participants' prescription profiles.
Primary Outcome Measure Information:
Title
Symptom Free Days
Description
Examine the efficacy of a school-based asthma telemedicine intervention.
Time Frame
The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Secondary Outcome Measure Information:
Title
Secondary Clinical Outcomes
Description
Secondary clinical outcomes will be measured at specific time points during the intervention.
Time Frame
Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara T. Perry, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
18939725
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
15356547
Citation
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.
Results Reference
background
PubMed Identifier
12135408
Citation
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.
Results Reference
background
PubMed Identifier
29471032
Citation
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.
Results Reference
derived

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Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children

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