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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Other: Interactive Video (IAV) Telemedicine; Behavioral: Standard of Care Education

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Interactive Video (IAV) Telemedicine; Interactive video assessment of asthma triggers in the home.
Active Comparator: 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.	Behavioral: Standard of Care Education; Education regarding recognition and removal of in-home asthma triggers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in asthma-related triggers	Changes in dust mite levels in home collected dust	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Asthma Control Test (ACT)	from baseline to 6 months	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	6 months
Patient Satisfaction	as assessed via survey	6 months

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Robert Pesek, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 239759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No