ENLaCE Pilot Study

Using MEDUCATION to Improve Asthma Medication Device Technique

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Meducation device technique video; Other: Nutrition video

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Thomasville, North Carolina, United States, 27360
      • Thomasville Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video intervention; Group that will watch the Meducation inhaler device technique videos.	Behavioral: Meducation device technique video; 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.
Other: Control; This group will watch a nutrition video.	Other: Nutrition video; Children in this group will watch a 2-minute nutrition video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?"	Baseline and 1-month follow-up
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.	Baseline and 1-month follow-up

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 12-1008