NCT02141893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

May 12, 2014

Last Update Submit

May 19, 2014

Conditions

Infantile Asthma

Outcome Measures

Primary Outcomes (1)

  • Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up

    Baseline, 12

Secondary Outcomes (1)

  • Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up

    baseline, 12

Study Arms (2)

CALMA

ACTIVE COMPARATOR

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

Behavioral: CALMA plusBehavioral: CALMA

Calma plus

EXPERIMENTAL

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

Interventions

CALMA plusBEHAVIORAL

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

CALMACalma plus
CALMABEHAVIORAL

Family Education Intervention on management of pediatric asthma

CALMA

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • had at least 2 Emergency Department (ED) visits
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Sciences Research Institute

San Juan, PR, 00936, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 26786240DERIVED

Study Officials

  • Glorisa Canino, PhD

    Medical Sciences Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Glorisa Canino

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 20, 2014

Study Start

December 1, 2009

Primary Completion

February 1, 2012

Study Completion

July 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

PR(1)