ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02141893
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Glorisa Canino, University of Puerto Rico

Brief 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.

Condition or disease Intervention/treatment Phase
Infantile Asthma Behavioral: CALMA plus Behavioral: CALMA Not Applicable

Detailed Description:
Puerto Rico has high rates of pediatric asthma and morbidity associated in part with poor family asthma management and low rates of controller medication use. A previous study found a family management intervention called CALMA to be effective in reducing asthma symptoms and service utilization. However, CALMA was not effective in increasing the use of controller medications. CALMA- plus was developed to address this issue by adding to CALMA components of educational training of physicians and nurses, and screening for asthma in clinics serving Medicaid Puerto Rican children with persistent asthma. A total of 404 children in eight clinics were studied after forming four pairs of clinics and randomizing the clinics (1:1) to CALMA-only or CALMA-plus within each pair. After adjusting for clinic variation, the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA- only intervention for increasing reported controller medication use or decreasing symptoms in children with persistent asthma. Both groups had lower rates of asthma symptoms and service utilization consistent with previous results of the CALMA-only intervention. Limitations of the study were small number of clinics available, comparison of the experimental intervention with an evidence based intervention, and limited exposure to some aspects of the intervention. More effective interventions may include aggressive case management, and providing the physician with more relevant information.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Study Start Date : December 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: CALMA
Participants only received a family education intervention (previously tested) known as CALMA
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

Experimental: Calma plus
Participants in Arm 2 received the CALMA family education intervention and 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 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




Primary Outcome Measures :
  1. Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up [ Time Frame: Baseline, 12 ]

Secondary Outcome Measures :
  1. Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up [ Time Frame: baseline, 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria required that the child have at least one claim with a diagnostic code for asthma or reactive airway disease (International Classification of Diseases (ICD 9) diagnostic code 493.xx) and in the last year period had either1) been hospitalized for asthma
  • had at least 2 Emergency Department (ED) visits
  • 3-5 ambulatory visits due to asthma
  • utilized asthma medications from 2 of the following therapeutic categories: Anticholinergics, cromolyn, sympathomimetics, steroid inhalants, methylxanthines, leukotriene inhibitors, or corticosteroids.

Exclusion Criteria:

  • currently participating in another asthma study
  • no appropriate address for follow-up in the claims data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141893


Locations
Puerto Rico
Behavioral Sciences Research Institute
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Glorisa Canino, PhD Medical Sciences Campus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glorisa Canino, University of Puerto Rico
ClinicalTrials.gov Identifier: NCT02141893     History of Changes
Other Study ID Numbers: GC- 0160609-CALMA
P60MD00226 ( Other Grant/Funding Number: National Center on Minority Health and Health Disparities )
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases