The Houston HIITBAC for African Americans

Asthma Clinical Trial

— HIIT-BAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253433
• Other study ID #: PCORI AS-1308-05887
• Secondary ID: H-34115
• Status: Completed
• Phase: N/A
• Start date: January 8, 2015
• Est. completion date: January 26, 2018

Study information

• Verified date: November 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• African-American

• 18 years of age or older

• Diagnosis of poorly controlled asthma*

• Fixed address within Harris County, Texas, with no intention of moving within the following 12 months

• Working telephone number

• Verbally fluent in English

• Poorly controlled asthma was defined as (1) diagnosed by a physician as having asthma in the past and currently has asthma, and (2) fulfills one or more of the following criteria: (a) one or more emergency department (ED), urgent care visits or hospitalizations for asthma in the preceding year; (b) meets the definition of "very poorly controlled" asthma as defined by the National Asthma Education and Prevention Program, Third Expert Panel on the Diagnosis and Management of Asthma (definition includes daily asthma symptoms, nighttime awakenings two or more times per week, extremely limited normal activity, and/or daily use of a short-acting beta agonist for symptom control); and/or (c) an Asthma Control Test score of 19 or lower.

EXCLUSION CRITERIA:

• Severe co-morbid conditions—such as a poorly controlled psychiatric illness or a condition requiring intense medical treatment that could reasonably be expected to (1) confound the effects of this study's intervention, (2) make it unlikely that a participant could follow the treatment plan, or (3) pose a safety issue for the home-visit team.

• A concurrent pulmonary study that could reasonably be expected to confound the effects of the intervention.

• Living in a group living facility, such as a nursing home.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Enhanced Clinic Care
The intervention includes a standard clinical appointment including spirometry, as well as collection of 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.
• Enhanced Clinic Care + Home Intervention
The home-based component includes environmental exposure assessment (observed and measured) and a multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).

Locations

Country	Name	City	State
United States	Harris Health Smith Clinic	Houston	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Baylor College of Medicine	Harris County Hospital District, Houston Department of Health and Human Services, M.D. Anderson Cancer Center, Texas A&M University, UTHealth School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Test (ACT) Score	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.	At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Primary	Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)	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).	At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Secondary	Change in Emergency Department (ED) Visits for Asthma	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.	At baseline (enrollment) and exit (approximately 12 mo after enrollment)