NCT02454192

Brief Summary

The purpose of this study is to systematically investigate across health center study sites participating in this study the process of adopting, integrating, implementing, and diffusing a minimum set of evidence-based interventions for the management of childhood asthma. Investigators hypothesized that an intervention that is evidence- and consensus-based (i.e., minimum elements to be integrated into existing practice, dosing of each element) would be implemented effectively, as measured by health center performance improvement on child health outcomes, health care utilization, and other measures (e.g., avoidable costs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
599

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2010

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

4.3 years

First QC Date

April 29, 2015

Last Update Submit

April 5, 2016

Conditions

Asthma

Keywords

Evidence-based interventionImplementationUnderserved communities

Outcome Measures

Primary Outcomes (1)

  • Asthma symptoms

    Reduction in asthma symptom days in the past 4 weeks as measured by the Asthma Symptoms and Utilization (ASU) questionnaire

    In the past 4 weeks

Secondary Outcomes (1)

  • Utilization of health care services

    In the past year

Other Outcomes (7)

  • Success of implementation

    5 years

  • Success of implementation

    5 years

  • Success of implementation

    5 years

  • +4 more other outcomes

Study Arms (2)

CHAMPS Intervention

OTHER

Tailored asthma education and counseling for children with moderate to severe asthma who have confirmed allergies to environmental triggers present in their homes provided through a combination of clinic and home visits

Behavioral: CHAMPS

Usual Care

NO INTERVENTION

Usual asthma care and management

Interventions

CHAMPSBEHAVIORAL
CHAMPS Intervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of asthma
  • Currently receiving long-term asthma control therapy and either has symptoms consistent with persistent asthma or has evidence of uncontrolled disease or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma and also has evidence of uncontrolled disease
  • Caretaker speaks English or Spanish

You may not qualify if:

  • Younger or older children
  • Mild, intermittent asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milken Institute School of Public Health

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anne R Markus, JD, PhD, MHS

    George Washington University

    PRINCIPAL INVESTIGATOR

  • Herman Mitchell, PhD

    Rho, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 27, 2015

Study Start

October 1, 2010

Primary Completion

January 1, 2015

Study Completion

March 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

US(1)