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Clinical Trials/NCT02253433
NCT02253433
Completed
N/A

The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans

Baylor College of Medicine1 site in 1 country264 target enrollmentJanuary 8, 2015
ConditionsAsthma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asthma
Sponsor
Baylor College of Medicine
Enrollment
264
Locations
1
Primary Endpoint
Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to improve the health of African-American adults who have poorly controlled asthma. The study compares a home-based exposure reduction and asthma control intervention to enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing. The interventional group receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).

Detailed Description

The study hypothesis is that the addition of a holistic, home-based environmental exposure reduction and asthma control intervention to enhanced in-clinic care will result in statistically significant improvements in key measures of health and quality of life among Houston-area African-American adults with poorly controlled asthma. This is a pragmatic randomized controlled clinical trial that compares the effectiveness of a customized, holistic, patient-centered, home-based environmental intervention for improving asthma control (the "intervention") with enhanced clinic-based care. Both arms receive identical in-clinic care, including collected self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing. The intent of the study is to assess-real-life effectiveness of a home-based intervention in African-American adults with poorly controlled asthma.

Registry
clinicaltrials.gov
Start Date
January 8, 2015
End Date
January 26, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winifred J. Hamilton, PhD

Director, Environmental Health Service

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)

Time Frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)

Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).

Change in Asthma Control Test (ACT) Score

Time Frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)

Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.

Secondary Outcomes

  • Change in Emergency Department (ED) Visits for Asthma(At baseline (enrollment) and exit (approximately 12 mo after enrollment))

Study Sites (1)

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