Clinical trial NCT05120323: vDOT for Newly Diagnosed Pediatric Asthma
Official title: Video Directly Observed Therapy (vDOT) to Improve Inhaler Technique Among Pediatric Patients With Newly Diagnosed Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They will be randomized to the intervention arm or standard of care arm.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Inhaler technique
timeFrame: 3 months
measure: Symptom-free days
timeFrame: 3 months
measure: Healthcare utilization
timeFrame: 3 months
measure: Medication Adherence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medical Sciences and Arkansas Children's Research Institute
name: Tamara T. Perry, MD
role: PRINCIPAL_INVESTIGATOR
References: