ENLaCE Pilot Study

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Meducation device technique video; Other: Nutrition video

• Registration Number: NCT01641211
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-16
• Primary Completion: 2013-03
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video intervention	Meducation device technique video	Group that will watch the Meducation inhaler device technique videos.
Control	Nutrition video	This group will watch a nutrition video.

Primary Outcome Measures

Name	Time	Method
Change in inhaler, turbuhaler, and diskus technique	Baseline and 1-month follow-up	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

Name	Time	Method
Child inhaler self-efficacy	Baseline and 1-month follow-up	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	Baseline and 1-month follow-up	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.

Trial Locations

Locations (1)

Thomasville Pediatrics; 🇺🇸 Thomasville, North Carolina, United States