Clinical trial NCT02253433: The Houston HIITBAC for African Americans
Official title: The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
environmental triggers
home-based intervention
asthma home visits
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Harris County Hospital District
name: Houston Department of Health and Human Services
name: Texas A&M University
name: M.D. Anderson Cancer Center
name: UTHealth School of Public Health
First posted: 2014-10-01
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Asthma Control Test (ACT) Score
timeFrame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
measure: Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)
timeFrame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Secondary outcomes:
measure: Change in Emergency Department (ED) Visits for Asthma
timeFrame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris Health Smith Clinic
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Winifred J Hamilton, PhD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruhl RJ, Perkison WB, Hanania NA, McNeill LH, Oluyomi AO, Fiesinger EB, Minard CG, Solomon A, Hamilton WJ; Patient/Stakeholder Advisory Board and other members of the HIITBAC Research Team:; Butler B, Caldwell J, Crosby E, Davis C, Galvan H, Harris R, Lacour-Chestnut F, Martin C, Pannell S, Phipps K, Richardson G, Solomon A, White W, Boles J, Rangel A, Virk R, Brock M, Guffey D, Ramamurthy U, Persse D, Maffei S, Chan W, Reyes B. Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial. Contemp Clin Trials. 2020 Apr;91:105977. doi: 10.1016/j.cct.2020.105977. Epub 2020 Mar 6.