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The Houston HIITBAC for African Americans (HIIT-BAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253433
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Harris County Hospital District
Houston Department of Health and Human Services
Texas A&M University
M.D. Anderson Cancer Center
UTHealth School of Public Health
Information provided by (Responsible Party):
Winifred J. Hamilton, PhD, Baylor College of Medicine

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).

Condition or disease Intervention/treatment Phase
Asthma Other: Enhanced Clinic Care Other: Enhanced Clinic Care + Home Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans
Actual Study Start Date : January 8, 2015
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced Clinic Care
This arm receives enhanced in-clinic care only.
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.

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

Other: 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).




Primary Outcome Measures :
  1. Change in Asthma Control Test (ACT) Score [ Time Frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment) ]
    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.

  2. Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) [ Time Frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment) ]
    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).


Secondary Outcome Measures :
  1. Change in Emergency Department (ED) Visits for Asthma [ Time Frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253433


Locations
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United States, Texas
Harris Health Smith Clinic
Houston, Texas, United States, 77054
Sponsors and Collaborators
Baylor College of Medicine
Harris County Hospital District
Houston Department of Health and Human Services
Texas A&M University
M.D. Anderson Cancer Center
UTHealth School of Public Health
Investigators
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Principal Investigator: Winifred J Hamilton, PhD, SM Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Winifred J. Hamilton, PhD, Baylor College of Medicine:
Study Protocol  [PDF] May 21, 2018
Informed Consent Form  [PDF] December 20, 2016
Statistical Analysis Plan  [PDF] September 9, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Winifred J. Hamilton, PhD, Director, Environmental Health Service, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02253433    
Other Study ID Numbers: PCORI AS-1308-05887
H-34115 ( Other Identifier: Baylor College of Medicine )
First Posted: October 1, 2014    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.bcm.edu/environmentalhealth
Keywords provided by Winifred J. Hamilton, PhD, Baylor College of Medicine:
asthma
environmental triggers
home-based intervention
asthma home visits
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases