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Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial

NCT02141893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2014-05-20

No results posted yet for this study

Summary

The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.

Conditions

  • Infantile Asthma

Interventions

BEHAVIORAL

CALMA plus

Participants received a family education intervention (previously tested) known as CALMA plus physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs

BEHAVIORAL

CALMA

Family Education Intervention on management of pediatric asthma

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Glorisa Canino, PhD · Medical Sciences Campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-02-29
Completion
2013-07-31

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141893 on ClinicalTrials.gov