Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers

Not Applicable

Completed

• Conditions: Asthma in Children

• Registration Number: NCT04896502
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study Start: 2019-09-26
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Primary Completion: 2022-08-08
• Study Completion: 2022-09-01
• Status Verified: 2023-03
• Results First Submitted: 2023-03-06
• Results First Submitted QC: 2024-06-03
• Results First Posted: 2024-09-23
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation	4 months	Comparison of D. pteronyssinus levels collected in participant homes at baseline and at end of study with measure of number of subjects with a significant change

Secondary Outcome Measures

Name	Time	Method
Differences in ACT Score Between Telemedicine and Standard of Care Groups	6 months	We will measure differences in ACT scores from baseline to 6 months between the Telemedicine and Standard of Care groups. Asthma Control Test (ACT) is a 5 question (\<12 years of age) or 7 question (\>/= 12 years of age) test utilized to assess asthma control. Scores range from 0 to 25. The maximum score is 25 and a score of 19 or less indicates "not well-controlled" asthma.
Patient Satisfaction	6 months	Patient satisfaction measured by standardized survey. Respondents were asked "How satisfied were you with your overall experience?" and were scored on a scale from "Complete Satisfied" to "Not at All Satisfied"

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States