N/A
Completed N=264
The Houston HIITBAC for African Americans
Source: ClinicalTrials.gov NCT02253433 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Change in Asthma Control Test (ACT) Score — 12.5; 12.5; 16.2; 16.8 score on a scale — p=0.575
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control Test (ACT) Score |
12.5; 12.5; 16.2; 16.8 | 0.575 |
| PRIMARY Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) |
3.3; 3.2; 4.3; 4.5 | 0.141 |
| SECONDARY Change in Emergency Department (ED) Visits for Asthma |
2.2; 2.6; 1.3; 1.1 | 0.043 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02253433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.