Back to resultsEffectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Primary Purpose
Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Education
Interactive Video (IAV) Telemedicine
Sponsored by
About this trial
This is an interventional prevention trial for Asthma in Children focused on measuring Asthma, Telemedicine
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 5 years and ≤ 18 years
- Have a diagnosis of persistent asthma as defined by national guidelines criteria1
- Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
- Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
- English speaking participants/parents
- Access to WIFI, smartphone or mobile device (tablet)
Exclusion Criteria:
- Age <5 or >18 years
- Non-English speaking participants/parents
- Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
- Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine Arm
Standard of Care Education
Arm Description
For the proposed study, participants will randomized to receive TM home assessments/interventions performed by a trained home visitor (HV) or standard of care asthma trigger education by the HV. Those who are randomized to TM home assessments/interventions will complete a baseline home assessment and two follow-up visits, 2 months apart. Visits will assess the presence of potential asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM participants will be provided education and materials necessary to reduce asthma triggers in the home. Follow-up visits will assess the interval change in presence of asthma triggers, change in daily asthma symptoms/exacerbations, and participant/family retention of education.
For subjects randomized to receive standard of care asthma education, written and verbal information will be provided regarding identification and removal of potential asthma triggers in the home but no formal assessment of the home will be performed, nor will participants in this arm receive trigger reduction materials.
Outcomes
Primary Outcome Measures
Change in asthma-related triggers
Changes in dust mite levels in home collected dust
Secondary Outcome Measures
Changes in Asthma Control Test (ACT)
from baseline to 6 months
Changes in healthcare utilization
measured as either an increase or decrease in visits to a healthcare provider and/or medication pick-up from baseline to end of study
Patient Satisfaction
as assessed via survey
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04896502
Brief Title
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Official Title
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. It is similar to using Face Time on a mobile device. Asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. Reducing these triggers in the home can improve asthma.
Detailed Description
In this study, supplies will be given to some participants to help reduce or remove triggers from the home. One example is dust mites. These are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. This study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
Asthma, Telemedicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Arm
Arm Type
Experimental
Arm Description
For the proposed study, participants will randomized to receive TM home assessments/interventions performed by a trained home visitor (HV) or standard of care asthma trigger education by the HV. Those who are randomized to TM home assessments/interventions will complete a baseline home assessment and two follow-up visits, 2 months apart. Visits will assess the presence of potential asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM participants will be provided education and materials necessary to reduce asthma triggers in the home. Follow-up visits will assess the interval change in presence of asthma triggers, change in daily asthma symptoms/exacerbations, and participant/family retention of education.
Arm Title
Standard of Care Education
Arm Type
Active Comparator
Arm Description
For subjects randomized to receive standard of care asthma education, written and verbal information will be provided regarding identification and removal of potential asthma triggers in the home but no formal assessment of the home will be performed, nor will participants in this arm receive trigger reduction materials.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Education
Intervention Description
Education regarding recognition and removal of in-home asthma triggers
Intervention Type
Other
Intervention Name(s)
Interactive Video (IAV) Telemedicine
Intervention Description
Interactive video assessment of asthma triggers in the home.
Primary Outcome Measure Information:
Title
Change in asthma-related triggers
Description
Changes in dust mite levels in home collected dust
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Changes in Asthma Control Test (ACT)
Description
from baseline to 6 months
Time Frame
6 months
Title
Changes in healthcare utilization
Description
measured as either an increase or decrease in visits to a healthcare provider and/or medication pick-up from baseline to end of study
Time Frame
6 months
Title
Patient Satisfaction
Description
as assessed via survey
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 5 years and ≤ 18 years
Have a diagnosis of persistent asthma as defined by national guidelines criteria1
Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
English speaking participants/parents
Access to WIFI, smartphone or mobile device (tablet)
Exclusion Criteria:
Age <5 or >18 years
Non-English speaking participants/parents
Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Pesek, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
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