ENLaCE Pilot Study

NCT ID: NCT01641211

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-04-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Video intervention

Group that will watch the Meducation inhaler device technique videos.

Group Type: EXPERIMENTAL

Meducation device technique video

Intervention Type: 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.

Control

This group will watch a nutrition video.

Group Type: OTHER

Nutrition video

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Nutrition video

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Delesha Carpenter, PhD, MSPH

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomasville Pediatrics

Thomasville, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25025548 (View on PubMed)

Other Identifiers

12-1008

Identifier Type: -

Identifier Source: org_study_id