vDOT for Newly Diagnosed Pediatric Asthma

NCT05120323 | Active Not Recruiting

• 1 other identifier: 273496
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

vDOT Intervention Group

EXPERIMENTAL

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

Standard Asthma Care Group

NO INTERVENTION

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.

Interventions

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.

vDOT Intervention Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Study Officials

• Tamara T. Perry, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants will have a follow up appointment at 3 months and the respiratory therapists will be blinded to the study treatment to assess the participant's inhaler technique.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Chief, Allergy and Immunology Division

Model Details: They will be randomized to the intervention arm or standard of care arm.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: November 3, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)