Back to resultsvDOT for Newly Diagnosed Pediatric Asthma
Primary Purpose
Asthma in Children
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vDOT Intervention Group
Sponsored by
About this trial
This is an interventional prevention trial for Asthma in Children
Eligibility Criteria
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.
Sites / Locations
- Arkansas Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
vDOT Intervention Group
Standard Asthma Care Group
Arm Description
The VDot group will submit videos via app to Emocha to have their inhaler technique graded to assess their inhaler technique.
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.
Outcomes
Primary Outcome Measures
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.
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).
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.
Medication Adherence
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05120323
First Posted
November 3, 2021
Last Updated
December 14, 2021
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05120323
Brief Title
vDOT for Newly Diagnosed Pediatric Asthma
Official Title
Video Directly Observed Therapy to Improve Inhaler Technique Among Pediatric Patients With Newly Diagnosed Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
They will be randomized to the intervention arm or standard of care arm.
Masking
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.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vDOT Intervention Group
Arm Type
Experimental
Arm Description
The VDot group will submit videos via app to Emocha to have their inhaler technique graded to assess their inhaler technique.
Arm Title
Standard Asthma Care Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
vDOT Intervention Group
Intervention Description
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 Outcome Measure Information:
Title
Inhaler technique
Description
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.
Time Frame
3 months
Title
Symptom-free days
Description
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).
Time Frame
3 months
Title
Healthcare utilization
Description
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.
Time Frame
3 months
Title
Medication Adherence
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey E Overman
Phone
501-364-2861
Email
leoverman@uams.edu
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Overman
Phone
501-364-2861
Email
leoverman@uams.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers. Only study staff will have access to individual participant data.
Learn more about this trial
vDOT for Newly Diagnosed Pediatric Asthma
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