NCT02768883

Brief Summary

The immediate goal of the Imperial County CER Asthma project is to identify strategies to improve asthma control among children 0-17 years old and the asthma control behaviors of their families, their health care providers, and the communities in which they live. Our long-term goal is to improve the quality of life of children with asthma and potentially reduce families' economic and social burdens of uncontrolled asthma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

3.9 years

First QC Date

May 9, 2016

Last Update Submit

July 12, 2017

Conditions

Keywords

Childhood asthmaLatino

Outcome Measures

Primary Outcomes (1)

  • Asthma Quality of Life

    http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html

    1 year

Study Arms (4)

Clinic + Home + Community

EXPERIMENTAL

Clinic Intervention = 4 clinical visits with provider over 12 months, 4 visits with clinic asthma educator Home Intervention = 4 home visits with community health worker over 2 months, 4 mailers, and 4 phone calls Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.

Behavioral: Respira Sano

Clinic + Community

EXPERIMENTAL

Clinic Intervention = 4 clinical visits with provider over 12 months, 4 visits with clinic asthma educator Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.

Behavioral: Respira Sano

Home + Community

EXPERIMENTAL

Home Intervention = 4 home visits with community health worker over 2 months, 4 mailers, and 4 phone calls Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.

Behavioral: Respira Sano

Community only

ACTIVE COMPARATOR

Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.

Behavioral: Respira Sano

Interventions

Respira SanoBEHAVIORAL

The intervention is all three components: clinic + home + community.

Clinic + CommunityClinic + Home + CommunityCommunity onlyHome + Community

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Lives in Imperial County (except cities of Winterhaven, Salton City, Palo Verde)
  • Have a child between the ages of 6 - 17 years with asthma
  • Speak Spanish or English
  • Consider the child to be Latino

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Behavioral and Community Health at San Diego State University

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • John P Elder, PhD MPH

    San Diego State University Graduate School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Public Health; and Adjunct Professor of Family and Preventive Medicine, UCSD

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

February 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations