ENLaCE Pilot Study

Asthma Clinical Trial

Official title:

Using MEDUCATION to Improve Asthma Medication Device Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641211
• Other study ID #: 12-1008
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: April 8, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Thomasville Pediatrics	Thomasville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No