ENLaCE Pilot Study
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meducation device technique video
Nutrition video
Sponsored by

About this trial
This is an interventional health services research trial for Asthma
Eligibility Criteria
Inclusion Criteria:
Children will be eligible if they:
- are ages 8 through 16 years,
- are able to speak English or Spanish,
- can read the assent form,
- are present at the visit with an adult caregiver (parent or legal guardian) who can speak English or Spanish and who is at least 18 years of age,
- have mild, moderate, or severe persistent asthma, and
- are present for an asthma-related visit (either acute or scheduled).
Sites / Locations
- Thomasville Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Video intervention
Control
Arm Description
Group that will watch the Meducation inhaler device technique videos.
This group will watch a nutrition video.
Outcomes
Primary Outcome Measures
Change in inhaler, turbuhaler, and diskus technique
Children will demonstrate how they use their metered-dose inhalers, turbuhalers, and diskuses using empty devices. The research assistant will record the number of steps performed correctly. Correct use of inhalers, diskuses, and turbuhalers will be measured as continuous variables.
Secondary Outcome Measures
Child inhaler self-efficacy
Child inhaler self-efficacy will be measured as a continuous variable using 1 item from the Bursch asthma management self-efficacy measure, "How sure are you that you can use your inhaler correctly?"
Asthma Control
The Asthma Control Test is a 5-item questionnaire assessing asthma symptoms, use of rescue medications, and the effect of asthma on daily functioning. Scores range from 5 (poor control) to 25 (complete control). Studies show that the Asthma Control Test is reliable, valid, and responsive to temporal changes in asthma control.
Full Information
NCT ID
NCT01641211
First Posted
July 9, 2012
Last Updated
April 8, 2013
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01641211
Brief Title
ENLaCE Pilot Study
Official Title
Using MEDUCATION to Improve Asthma Medication Device Technique
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a feasibility study to determine whether the Expanding Networks for Latinos through Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected. The investigators hypothesize that children in the intervention group will have better device technique post-intervention than the control group.
Detailed Description
Asthma affects almost 10% of children and is the most common health condition reported by North Carolina public schools. Latino children have higher rates of uncontrolled asthma and more asthma-related emergency department visits than their White counterparts. No studies have evaluated Latino children's asthma device technique; poor technique can compromise medication delivery to the lungs.
The TraCS engagement core has spent the last 18 months developing the Expanding Networks for Latinos through Community Engagement (ENLaCE) network, which is comprised of over 15 organizations in the Greensboro area. The core would now like to conduct a feasibility study to determine whether ENLaCE can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. This would be the first assessment of whether ENLaCE can be used to recruit patients.
MEDUCATION, an NIH-funded project developed by Polyglot Systems, Inc., has developed asthma device technique videos in Spanish and English. The member groups of ENLaCE believe the MEDUCATION videos are highly relevant for the Greensboro Latino community. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video intervention
Arm Type
Experimental
Arm Description
Group that will watch the Meducation inhaler device technique videos.
Arm Title
Control
Arm Type
Other
Arm Description
This group will watch a nutrition video.
Intervention Type
Behavioral
Intervention Name(s)
Meducation device technique video
Intervention Description
2-minute video that displays proper inhaler, diskus, and turbuhaler technique. The video will only be watched once at the medical visit. Children in this group will be given a wallet card so they can access the video via the Internet after leaving the asthma clinic.
Intervention Type
Other
Intervention Name(s)
Nutrition video
Intervention Description
Children in this group will watch a 2-minute nutrition video.
Primary Outcome Measure Information:
Title
Change in inhaler, turbuhaler, and diskus technique
Description
Children will demonstrate how they use their metered-dose inhalers, turbuhalers, and diskuses using empty devices. The research assistant will record the number of steps performed correctly. Correct use of inhalers, diskuses, and turbuhalers will be measured as continuous variables.
Time Frame
Baseline and 1-month follow-up
Secondary Outcome Measure Information:
Title
Child inhaler self-efficacy
Description
Child inhaler self-efficacy will be measured as a continuous variable using 1 item from the Bursch asthma management self-efficacy measure, "How sure are you that you can use your inhaler correctly?"
Time Frame
Baseline and 1-month follow-up
Title
Asthma Control
Description
The Asthma Control Test is a 5-item questionnaire assessing asthma symptoms, use of rescue medications, and the effect of asthma on daily functioning. Scores range from 5 (poor control) to 25 (complete control). Studies show that the Asthma Control Test is reliable, valid, and responsive to temporal changes in asthma control.
Time Frame
Baseline and 1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children will be eligible if they:
are ages 8 through 16 years,
are able to speak English or Spanish,
can read the assent form,
are present at the visit with an adult caregiver (parent or legal guardian) who can speak English or Spanish and who is at least 18 years of age,
have mild, moderate, or severe persistent asthma, and
are present for an asthma-related visit (either acute or scheduled).
Facility Information:
Facility Name
Thomasville Pediatrics
City
Thomasville
State/Province
North Carolina
ZIP/Postal Code
27360
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25025548
Citation
Carpenter DM, Lee C, Blalock SJ, Weaver M, Reuland D, Coyne-Beasley T, Mooneyham R, Loughlin C, Geryk LL, Sleath BL. Using videos to teach children inhaler technique: a pilot randomized controlled trial. J Asthma. 2015 Feb;52(1):81-7. doi: 10.3109/02770903.2014.944983. Epub 2014 Jul 31.
Results Reference
derived
Learn more about this trial
ENLaCE Pilot Study
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