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

NCT04896502 | Completed Results

• 1 other identifier: 239759
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

Asthma; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation

  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

  4 months

Secondary Outcomes (2)

• Differences in ACT Score Between Telemedicine and Standard of Care Groups

  6 months

• Patient Satisfaction

  6 months

Study Arms (2)

Telemedicine Arm

EXPERIMENTAL

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

Standard of Care Education

ACTIVE COMPARATOR

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

Interventions

Standard of Care Education BEHAVIORAL

Education regarding recognition and removal of in-home asthma triggers

Standard of Care Education

Interactive Video (IAV) Telemedicine OTHER

Interactive video assessment of asthma triggers in the home.

Telemedicine Arm

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥ 5 years and ≤ 18 years
• Have a diagnosis of persistent asthma as defined by national guidelines criteria1
• Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
• 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
• English speaking participants/parents
• Access to WIFI, smartphone or mobile device (tablet)

You may not qualify if:

• Age \<5 or \>18 years
• Non-English speaking participants/parents
• Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
• Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Robbie Pesek, MD
• Organization: Arkansas Children's Hospital

rdpesek@uams.edu

501-364-3149

Study Officials

• Robert Pesek, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: September 26, 2019
• Primary Completion: August 8, 2022
• Study Completion: September 1, 2022
• Last Updated: October 17, 2024
• Results First Posted: September 23, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)