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

May 19, 2014 updated by: Glorisa Canino, University of Puerto Rico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Behavioral Sciences Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up
Time Frame: Baseline, 12
Baseline, 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up
Time Frame: baseline, 12
baseline, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Glorisa Canino, PhD, Medical Sciences Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC- 0160609-CALMA
  • P60MD00226 (Other Grant/Funding Number: National Center on Minority Health and Health Disparities)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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