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Completed

NCT Number: NCT01641211

ENLaCE Pilot Study

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomasville Pediatrics

Thomasville, North Carolina, 27360, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Meducation device technique video

Behavioral

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.

Nutrition video

Other

Children in this group will watch a 2-minute nutrition video.

Primary outcomes

  1. Change in inhaler, turbuhaler, and diskus technique

    Time frame: 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 outcomes

  1. Child inhaler self-efficacy

    Time frame: 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?"

  2. Asthma Control

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Using MEDUCATION to Improve Asthma Medication Device Technique

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2012
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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