vDOT for Newly Diagnosed Pediatric Asthma

Video Directly Observed Therapy (vDOT) to Improve Inhaler Technique Among Pediatric Patients With Newly Diagnosed Asthma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: vDOT Intervention Group

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• 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: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

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: vDOT Intervention Group; The VDot group will submit videos via app to Emocha to have their inhaler technique graded to assess their inhaler technique.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhaler technique	For all participants, the inhaler technique checklist will be completed at the baseline and 3-month visits. The rate of inhaler technique accuracy (absence of errors, yes/no) at 3-months will be compared between the vDOT intervention and standard asthma care groups (primary outcome). The number and type of technique errors for both groups will be recorded at 3-months. b. For intervention participants only, each (daily) submitted video will receive 2 ratings to record a numeric score (0-10) and a yes/no accuracy score. The number and type of technique errors (i.e. did not shake inhaler, did not hold breath, etc) during the first 30 days will be assessed. The length of time to technique mastery (technique accuracy doses x 3 consecutive doses) will be recorded.	3 months
Symptom-free days	We will measure the change from baseline in the number of SFD during the prior 2 weeks, assessed at the end of the 3-month intervention period. This outcome measure is consistent with the symptom monitoring suggested by the national guidelines for asthma care and has been suggested as an appropriate surrogate marker for asthma control. We will ask parents to report the number of days during the prior 2 weeks that their child experienced no symptoms of asthma (defined as a 24 hour period with no coughing, wheezing, chest tightness, or shortness of breath, and no need for rescue medications).	3 months
Healthcare utilization	Questions regarding healthcare utilization and asthma exacerbations will be included. We will ask caregivers to report the number of steroid bursts, unscheduled (acute) healthcare visits, emergency room visits, and hospitalizations due to asthma in the past 3 months at the baseline and 3-month visit.	3 months
Medication Adherence	As a proxy of medication adherence, we will measure the proportion of days covered (PDC) of their inhaled asthma medication for the 90 days (3 months) while enrolled in the proposed study.	3 months

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Investigators: Principal Investigator: Tamara T. Perry, MD, University of Arkansas for Medical Sciences and Arkansas Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• 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: 273496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers. Only study staff will have access to individual participant data.

Drug and device information, study documents

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