Asthma
Conditions
Keywords
asthma, environmental triggers, home-based intervention, asthma home visits
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.
Interventions
OTHEREnhanced 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.
OTHEREnhanced 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).
Sponsors
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
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test (ACT) Score | 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. |
| Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Emergency Department (ED) Visits for Asthma | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Clinic Care This arm will receive 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. | 130 |
| Enhanced Clinic Care + Home Intervention This arm 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).
Enhanced in-clinic care and intervention: This arm 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). | 134 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Medical or Other Concerns | 1 | 2 |
| Overall Study | No Longer Interested | 3 | 15 |
| Overall Study | Out of Study Area | 2 | 7 |
| Overall Study | Too Busy | 0 | 4 |
| Overall Study | Unable to Contact | 9 | 16 |
| Overall Study | Uncomfortable with home visitors | 0 | 3 |
| Overall Study | Unstable Housing/Homeless | 0 | 7 |
Baseline characteristics
| Characteristic | Total | Enhanced Clinic Care | Enhanced Clinic Care + Home Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 13 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 235 Participants | 117 Participants | 118 Participants |
| Age, Continuous | 50.2 years STANDARD_DEVIATION 13 | 49.4 years STANDARD_DEVIATION 12.7 | 51.0 years STANDARD_DEVIATION 13.3 |
| Asthma Control Test (ACT) | 12.5 units on a scale STANDARD_DEVIATION 4.3 | 12.5 units on a scale STANDARD_DEVIATION 4.3 | 12.5 units on a scale STANDARD_DEVIATION 4.2 |
| Body Mass Index (BMI) | 35.2 kg/m^2 STANDARD_DEVIATION 10.4 | 36.0 kg/m^2 STANDARD_DEVIATION 10.6 | 34.4 kg/m^2 STANDARD_DEVIATION 10.1 |
| Juniper Mini Asthma Quality of Life Questionnaire | 3.2 units on a scale STANDARD_DEVIATION 1.1 | 3.3 units on a scale STANDARD_DEVIATION 1.2 | 3.2 units on a scale STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 264 Participants | 130 Participants | 134 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 264 participants | 130 participants | 134 participants |
| Sex: Female, Male Female | 196 Participants | 98 Participants | 98 Participants |
| Sex: Female, Male Male | 68 Participants | 32 Participants | 36 Participants |
| Total Immunoglobulin E (Total IgE) | 597.6 kU/L STANDARD_DEVIATION 1351.2 | 550.5 kU/L STANDARD_DEVIATION 1479.8 | 643.2 kU/L STANDARD_DEVIATION 1217.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 130 | 1 / 134 |
| other Total, other adverse events | 0 / 130 | 0 / 134 |
| serious Total, serious adverse events | 0 / 130 | 0 / 134 |
Outcome results
Primary
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.
Time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Population: At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Clinic Care | Change in Asthma Control Test (ACT) Score | Baseline | 12.5 score on a scale | Standard Deviation 4.3 |
| Enhanced Clinic Care | Change in Asthma Control Test (ACT) Score | Exit | 16.2 score on a scale | Standard Deviation 5.1 |
| Enhanced Clinic Care + Home Intervention | Change in Asthma Control Test (ACT) Score | Baseline | 12.5 score on a scale | Standard Deviation 4.2 |
| Enhanced Clinic Care + Home Intervention | Change in Asthma Control Test (ACT) Score | Exit | 16.8 score on a scale | Standard Deviation 5.1 |
p-value: 0.57595% CI: [-0.87, 2.07]Mixed Models Analysis
Primary
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).
Time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Population: Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Clinic Care | Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) | Baseline | 3.3 score on a scale | Standard Deviation 1.2 |
| Enhanced Clinic Care | Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) | Exit | 4.3 score on a scale | Standard Deviation 1.5 |
| Enhanced Clinic Care + Home Intervention | Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) | Baseline | 3.2 score on a scale | Standard Deviation 1.1 |
| Enhanced Clinic Care + Home Intervention | Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ) | Exit | 4.5 score on a scale | Standard Deviation 1.5 |
p-value: 0.14195% CI: [-0.18, 0.68]Mixed Models Analysis
Secondary
Change in Emergency Department (ED) Visits for Asthma
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.
Time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Population: One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 control and 79 intervention completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Clinic Care | Change in Emergency Department (ED) Visits for Asthma | Baseline | 2.2 visits | Standard Deviation 3.5 |
| Enhanced Clinic Care | Change in Emergency Department (ED) Visits for Asthma | Exit | 1.3 visits | Standard Deviation 2.4 |
| Enhanced Clinic Care + Home Intervention | Change in Emergency Department (ED) Visits for Asthma | Baseline | 2.6 visits | Standard Deviation 3.5 |
| Enhanced Clinic Care + Home Intervention | Change in Emergency Department (ED) Visits for Asthma | Exit | 1.1 visits | Standard Deviation 2 |
p-value: 0.04395% CI: [0.47, 1.57]Mixed Models Analysis