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

NCT ID: NCT02141893

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-07-31

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.

Conditions

Infantile Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CALMA

Participants only received a family education intervention (previously tested) known as CALMA

Group Type: ACTIVE_COMPARATOR

CALMA plus

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Family Education Intervention on management of pediatric asthma

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.

Group Type: EXPERIMENTAL

CALMA plus

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

CALMA

Family Education Intervention on management of pediatric asthma

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Glorisa Canino

Glorisa Canino

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glorisa Canino, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Sciences Campus

Locations

Behavioral Sciences Research Institute

San Juan, PR, Puerto Rico

Countries

Puerto Rico

References

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.

Reference Type: DERIVED

PMID: 26786240 (View on PubMed)

Other Identifiers

P60MD00226

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GC- 0160609-CALMA

Identifier Type: -

Identifier Source: org_study_id