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The Houston HIITBAC for African Americans

Not Applicable
Completed
Conditions
Asthma
Interventions
Other: Enhanced Clinic Care
Other: Enhanced Clinic Care + Home Intervention
Registration Number
NCT02253433
Lead Sponsor
Baylor College of Medicine
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
264
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced Clinic Care + Home InterventionEnhanced Clinic CareThis arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.
Enhanced Clinic CareEnhanced Clinic CareThis arm receives enhanced in-clinic care only.
Enhanced Clinic Care + Home InterventionEnhanced Clinic Care + Home InterventionThis arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.
Primary Outcome Measures
NameTimeMethod
Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)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) ScoreAt 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 Outcome Measures
NameTimeMethod
Change in Emergency Department (ED) Visits for AsthmaAt baseline (enrollment) and exit (approximately 12 mo after enrollment)

Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked "During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?". We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.

Trial Locations

Locations (1)

Harris Health Smith Clinic

🇺🇸

Houston, Texas, United States

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