Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Primary Purpose
Infantile Asthma
Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
CALMA plus
CALMA
Sponsored by

About this trial
This is an interventional treatment trial for Infantile Asthma
Eligibility 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.
Sites / Locations
- Behavioral Sciences Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CALMA
Calma plus
Arm Description
Participants only received a family education intervention (previously tested) known as CALMA
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.
Outcomes
Primary Outcome Measures
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up
Secondary Outcome Measures
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up
Full Information
NCT ID
NCT02141893
First Posted
May 12, 2014
Last Updated
May 19, 2014
Sponsor
University of Puerto Rico
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT02141893
Brief Title
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Official Title
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CALMA
Arm Type
Active Comparator
Arm Description
Participants only received a family education intervention (previously tested) known as CALMA
Arm Title
Calma plus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CALMA plus
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
CALMA
Intervention Description
Family Education Intervention on management of pediatric asthma
Primary Outcome Measure Information:
Title
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up
Time Frame
Baseline, 12
Secondary Outcome Measure Information:
Title
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up
Time Frame
baseline, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glorisa Canino, PhD
Organizational Affiliation
Medical Sciences Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Sciences Research Institute
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
26786240
Citation
Canino G, Shrout PE, Vila D, Ramirez R, Rand C. Effectiveness of a multi-level asthma intervention in increasing controller medication use: a randomized control trial. J Asthma. 2016;53(3):301-10. doi: 10.3109/02770903.2015.1057846. Epub 2016 Jan 19.
Results Reference
derived
Learn more about this trial
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
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