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The Houston HIITBAC for African Americans (HIIT-BAC)

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Asthma

Treatments

Other: Enhanced Clinic Care
Other: Enhanced Clinic Care + Home Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02253433
H-34115 (Other Identifier)
PCORI AS-1308-05887

Details and patient eligibility

About

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).

Full 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.

Enrollment

264 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

264 participants in 2 patient groups

Enhanced Clinic Care
Experimental group
Description:
This arm receives enhanced in-clinic care only.
Treatment:
Other: Enhanced Clinic Care
Enhanced Clinic Care + Home Intervention
Experimental group
Description:
This arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.
Treatment:
Other: Enhanced Clinic Care + Home Intervention
Other: Enhanced Clinic Care

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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