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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04896502
Other study ID # 239759
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2019
Est. completion date September 1, 2022

Study information

Verified date April 2022
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 1, 2022
Est. primary completion date August 8, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: 1. Age = 5 years and = 18 years 2. Have a diagnosis of persistent asthma as defined by national guidelines criteria1 3. Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics 4. 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 5. English speaking participants/parents 6. Access to WIFI, smartphone or mobile device (tablet) Exclusion Criteria: 1. Age <5 or >18 years 2. Non-English speaking participants/parents 3. Patients not receiving primary and/or asthma specialty care or inpatient services at ACH 4. Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard of Care Education
Education regarding recognition and removal of in-home asthma triggers
Other:
Interactive Video (IAV) Telemedicine
Interactive video assessment of asthma triggers in the home.

Locations

Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in asthma-related triggers Changes in dust mite levels in home collected dust 4 months
Secondary Changes in Asthma Control Test (ACT) from baseline to 6 months 6 months
Secondary 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 6 months
Secondary Patient Satisfaction as assessed via survey 6 months
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