vDOT for Newly Diagnosed Pediatric Asthma

Not Applicable

Active, not recruiting

• Conditions: Asthma in Children
• Interventions: Behavioral: vDOT Intervention Group

• Registration Number: NCT05120323
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Study Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Primary Completion: 2022-08-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Inhaler technique	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.
Symptom-free days	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).
Healthcare utilization	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.
Medication Adherence	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.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States