vDOT for Newly Diagnosed Pediatric Asthma

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05120323
Collaborator
(none)
20
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2
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Study Details

Study Description

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, 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: vDOT Intervention Group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
They will be randomized to the intervention arm or standard of care arm.They will be randomized to the intervention arm or standard of care arm.
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Video Directly Observed Therapy to Improve Inhaler Technique Among Pediatric Patients With Newly Diagnosed Asthma
Actual Study Start Date :
Nov 3, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. 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.

  4. Medication Adherence [3 months]

    s 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arkansas Children's Hospital Little Rock Arkansas United States 72202

Sponsors and Collaborators

  • Arkansas Children's Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamara Perry, Professor of Pediatrics, Chief, Allergy and Immunology Division, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT05120323
Other Study ID Numbers:
  • 273496
First Posted:
Nov 15, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2021