vDOT for Newly Diagnosed Pediatric Asthma

NCT ID: NCT05120323

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2024-12-30

Brief Summary

The goal of this research study is to compare the impact of video directly observed therapy on inhaler technique accuracy with participants receiving video directly observed therapy vs. participants receiving standard asthma care. Participants will be randomized between the two groups. We will follow up and compare the two groups to see if they have improved asthma control as measured by symptom-free days (SFD), higher inhaler technique at 3-month follow up, higher checklist scores on a standardized inhaler technique checklist, higher proportion of days covered (PDC) of their inhaled asthma controller medication, and have fewer acute care visits for asthma.

Detailed Description

Emocha® was originally developed by researchers at the Johns Hopkins University School of Medicine, the HIPAA-compliant platform was commercialized in 2014. Emocha® platform uses virtual communication tools (e.g. asynchronous video technology and secure 2-way messaging) to support and encourage adherence through timely feedback and positive reinforcement: helping users develop healthy behaviors and maintain high levels of medication adherence. The company leverages a public health practice called Directly Observed Therapy (DOT). DOT is a Center for Disease Control (CDC)-endorsed model of care that has been used by public health departments for decades to contain deadly infectious diseases.

Our overarching hypothesis is that compared to standard asthma medication education, vDOT will improve accuracy of inhaler technique (primary aim) and improve clinical outcomes such as medication adherence and asthma symptoms among children newly referred to asthma specialty clinic or those with a new inhaled asthma medication inhaler type.

Conditions

Asthma in Children

Study Design

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

Study Groups

vDOT Intervention Group

The VDot group will submit videos via app to Emocha to have their inhaler technique graded to assess their inhaler technique.

Group Type: EXPERIMENTAL

vDOT Intervention Group

Intervention Type: BEHAVIORAL

The vDOT intervention group will submit video clips of doses of inhaled controller asthma medication via the Emocha® smartphone application with each prescribed dose of inhaled controller medication. Each video will include a date and time stamp of the medication dose. Participant videos will be evaluated by trained personnel using an inhaler technique checklist to score each dose and create a report detailing the steps that were taken to complete the medication dose.

Standard Asthma Care Group

Participants in the standard asthma care group will receive standard of care asthma education conducted by a respiratory therapist in the specialty clinics at Arkansas Children's Hospital at the baseline visit. Education will include standard of care instruction on the participant's prescribed asthma medications, how to use an asthma action plan, as well as training and demonstration of proper inhaler technique. They will not have any additional study activities until the 3-month visit. They will be instructed to take their medications as prescribed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

vDOT Intervention Group

The vDOT intervention group will submit video clips of doses of inhaled controller asthma medication via the Emocha® smartphone application with each prescribed dose of inhaled controller medication. Each video will include a date and time stamp of the medication dose. Participant videos will be evaluated by trained personnel using an inhaler technique checklist to score each dose and create a report detailing the steps that were taken to complete the medication dose.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 6 and ≤ 11 years old

2. Physician diagnosed persistent asthma (any severity) and verified by review of electronic medical record

3. New patient with a new prescription for inhaled preventive asthma medication referred to an asthma subspecialty clinic at Arkansas Children's OR established patient in the asthma, allergy or pulmonary subspecialty clinic with a new prescription for inhaled preventive asthma medication.

4. Regular access to Wi-Fi

Exclusion Criteria

1. Significant underlying respiratory disease other than asthma such as cystic fibrosis

2. Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the ability to communicate via interactive video

3. Current smoker

4. Caregiver/patient does not have access to a smartphone compatible with the Emocha® smartphone application

5. Caregiver and patient speaks and understands English as their primary language.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Tamara Perry

Professor of Pediatrics, Chief, Allergy and Immunology Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara T. Perry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas for Medical Sciences and Arkansas Children's Research Institute

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

273496

Identifier Type: -

Identifier Source: org_study_id