Clinical trial NCT01641211: ENLaCE Pilot Study
Official title: Using MEDUCATION to Improve Asthma Medication Device Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 92
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Change in inhaler, turbuhaler, and diskus technique
timeFrame: Baseline and 1-month follow-up
Secondary outcomes:
measure: Child inhaler self-efficacy
timeFrame: Baseline and 1-month follow-up
measure: Asthma Control
timeFrame: Baseline and 1-month follow-up
Other outcomes:
Locations:
city: Thomasville
country: United States
facility: Thomasville Pediatrics
state: North Carolina
Study officials:
References:
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.