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

Infantile Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141893
• Other study ID #: GC- 0160609-CALMA
• Secondary ID: P60MD00226
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 19, 2014
• Start date: December 2009
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Center on Minority Health and Health Disparities
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: July 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Infantile Asthma

Intervention

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
• CALMA
Family Education Intervention on management of pediatric asthma

Locations

Country	Name	City	State
Puerto Rico	Behavioral Sciences Research Institute	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up		Baseline, 12	No
Secondary	Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up		baseline, 12	No