The Houston HIITBAC for African Americans
HIIT-BAC
The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans
2 other identifiers
interventional
264
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Jan 2015
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedNovember 14, 2018
November 1, 2018
3.1 years
September 29, 2014
May 31, 2018
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (1)
Change in Emergency Department (ED) Visits for Asthma
At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Study Arms (2)
Enhanced Clinic Care
EXPERIMENTALThis arm receives enhanced in-clinic care only.
Enhanced Clinic Care + Home Intervention
EXPERIMENTALThis arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- African-American
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- Harris County Hospital Districtcollaborator
- Houston Department of Health and Human Servicescollaborator
- Texas A&M Universitycollaborator
- M.D. Anderson Cancer Centercollaborator
- UTHealth School of Public Healthcollaborator
Study Sites (1)
Harris Health Smith Clinic
Houston, Texas, 77054, United States
Related Publications (1)
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.
PMID: 32151753DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Winifred J. Hamilton
- Organization
- Environmental Health, Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Winifred J Hamilton, PhD, SM
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Environmental Health Service
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 1, 2014
Study Start
January 8, 2015
Primary Completion
January 26, 2018
Study Completion
January 26, 2018
Last Updated
November 14, 2018
Results First Posted
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 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
- 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.
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.