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

NCT ID: NCT04896502

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2022-09-01

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Telemedicine Arm

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.

Group Type: EXPERIMENTAL

Interactive Video (IAV) Telemedicine

Intervention Type: OTHER

Interactive video assessment of asthma triggers in the home.

Standard of Care 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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Education

Intervention Type: BEHAVIORAL

Education regarding recognition and removal of in-home asthma triggers

Interventions

Standard of Care Education

Education regarding recognition and removal of in-home asthma triggers

Intervention Type: BEHAVIORAL

Interactive Video (IAV) Telemedicine

Interactive video assessment of asthma triggers in the home.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Pesek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

239759

Identifier Type: -

Identifier Source: org_study_id