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).

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.

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.

Participants receive their individual laboratory, exposure and other data, as well as their customized asthma control plan, to help them manage their asthma. This information is delivered to participants at clinic and/or at home visits as appropriate. Laboratory results may be mailed as well. Aggregate data were made available to participants at a regional Town Hall 5/1/2018 and by mail as requested at exit by participants. Aggregate and/or de-identified data were and are being made available to the Patient / Stakeholder Advisory Board and to researchers through presentations, websites, publications and data sharing arrangements. No identifiable IDP will be made available to other researchers except through consent of the participant and IRB approval.

The study protocol and ICF have been shared and are available on request. At the aggregate level, the initial findings of the pragmatic clinical trial were made available to our Patient/Stakeholder Advisory Panel at the February 12, 2018 meeting of the panel; at a regional Town Hall on asthma on May 1, 2018; and to participants who requested results by mail in November 2018. The Draft Final Research Report was submitted to PCORI in September 2018 and is undergoing external peer review. Two manuscripts--on methods and initial results--are being finalized for journal submission. The SAP and analytic code are currently undergoing refinement as we begin our secondary analyses and should be available in 2019.

Access criteria are based on protection of individual participant data as described in the protocol and ICF. Aggregate and de-identified data will be made available electronically, in the Rice University Kinder Urban Data Base Platform, and in presentations and manuscripts.

12 months

Limitations included (1) lack of a control group (the enhanced clinic visit = a robust intervention), (2) mobility of the participants, (3) disproportionate lost to follow-up, (4) missing data, (5) out-of-window encounters, and (6) Hurricane Harvey.