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NCT Number: NCT05120323

vDOT for Newly Diagnosed Pediatric 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma in Children

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 6 and ≤ 11 years old
  • Physician diagnosed persistent asthma (any severity) and verified by review of electronic medical record
  • 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.
  • Regular access to Wi-Fi

Exclusion criteria

  • Significant underlying respiratory disease other than asthma such as cystic fibrosis
  • Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the ability to communicate via interactive video
  • Current smoker
  • Caregiver/patient does not have access to a smartphone compatible with the Emocha® smartphone application
  • Caregiver and patient speaks and understands English as their primary language.

Treatment and study plan

vDOT Intervention Group

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.

Primary outcomes

  1. Inhaler technique

    Time frame: 3 months

    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.

  2. Symptom-free days

    Time frame: 3 months

    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. Healthcare utilization

    Time frame: 3 months

    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.

  4. Medication Adherence

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Nov 15, 2021
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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