NCT01641211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

July 9, 2012

Last Update Submit

April 8, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Child inhaler self-efficacy

    Baseline and 1-month follow-up

  • Asthma Control

    Baseline and 1-month follow-up

Study Arms (2)

Video intervention

EXPERIMENTAL

Group that will watch the Meducation inhaler device technique videos.

Behavioral: Meducation device technique video

Control

OTHER

This group will watch a nutrition video.

Other: Nutrition video

Interventions

Meducation device technique videoBEHAVIORAL

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.

Video intervention
Nutrition videoOTHER

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

Control

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomasville Pediatrics

Thomasville, North Carolina, 27360, United States

Location

Related Publications (1)

  • 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.

    PMID: 25025548DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 16, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

US(1)