Clinical trial NCT04896502: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma
Telemedicine
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation
timeFrame: 4 months
Secondary outcomes:
measure: Differences in ACT Score Between Telemedicine and Standard of Care Groups
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Robert Pesek, MD
role: PRINCIPAL_INVESTIGATOR
References: