Houston Breathe Easy Healthy Homes-Based Model for Multifamily Rental Communities

Study Overview
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Brief Summary
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The primary purpose of this pragmatic randomized clinical trial is to examine whether the addition of a phone-based multicomponent environmental intervention customized for Houston public housing residents with asthma will result in statistically significant improvements in key measures of health, quality of life, and resilience.

Detailed Description
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This is a pragmatic randomized clinical trial that examines the effectiveness of a clinically informed phone-based environmental intervention for improving asthma control in individuals living in selected Houston Housing Authority public housing communities. This study was initially designed as an in-home intervention but changed to a phone-based intervention, with drop-offs of supplies and other materials, because of the coronavirus pandemic. Both the control and intervention groups complete a comprehensive set of questionnaires by phone (or online or on paper), and wear a passive wristband collection device for seven days that measures exposure to 1,530 chemicals. Each enrollee is randomly assigned into one of the two groups after the baseline questionnaires are completed. The intervention (exposure-reduction) group receives a telehealth visit, a customized Multicomponent Asthma Action Plan, multiple phone-based intervention visits and customized exposure-reduction supplies and materials, delivered to their porch, to implement the plan and support behavior change. The exposure-reduction group is encouraged to provide a blood sample to a local Harris Health laboratory for analysis of allergic and eosinophilic status. The control (phone-call-only) group receives phone follow-up calls. Six months after the baseline assessment, both groups are reassessed at the exit visit. The phone-call-only group receives the exposure-reduction intervention after the exit visit.

Official Title
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Phase 2 of the Houston Breathe Easy Healthy Homes-Based Model for Multifamily Rental Communities: Pragmatic Clinical Trial

Conditions
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Asthma, Respiratory Tract Disease, Lung Diseases, Sinusitis, Chronic

Intervention / Treatment
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* Behavioral: Exposure-Reduction Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Diagnosis of poorly controlled asthma* Live in one of the selected public housing communities operated by the Houston Housing Authority No clear plan to move within the next 6 months Working telephone number Able to read and speak in English Poorly controlled asthma defined as (1) has been diagnosed by a physician as having asthma in the past and currently has asthma; and (2) fulfills one or more of the following criteria of poorly controlled asthma: has had one or more emergency department visits or hospitalizations for asthma in the preceding year; has had asthma symptoms during the daytime at least two days in the past week; has been awoken at night by asthma symptoms one or more nights in the past week; or has used asthma rescue medication at least twice in the past week. These eligibility criteria effectively include two categories of asthma control as defined by the National Asthma Education and Prevention Program, (NAEPP) Third Expert Panel (EPR3) on the Diagnosis and Management of Asthma: not well controlled and very poorly controlled asthma. 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 or (2) make it unlikely that a participant could follow the treatment plan. A concurrent pulmonary study that could reasonably be expected to confound the effects of the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure-Reduction Intervention Group<br>The exposure-reduction (intervention) group receives a phone-based telehealth visit, collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies (optional), a customized asthma self-management plan and support developed using motivational interviewing methods, and a customized selection of supplies to help reduce key exposures likely exacerbating asthma symptoms. | Behavioral: Exposure-Reduction Intervention<br>* The customized exposure-reduction intervention includes a phone-based telehealth visit, collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies (optional), and a customized asthma self-management and exposure-reduction plan developed using motivational interviewing techniques, support, and exposure-reduction supplies.<br>|
| No Intervention: Phone-Call-Only Control Group<br>The phone-call-only (control) group provides self-reported information about health and environmental exposures. They receive follow-up phone calls every 6 weeks to maintain contact only. After exit, the phone-call-only (control) group receives assessment for allergies (optional) and the exposure-reduction intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Control Test (ACT) Score | 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 asthma control. | Measured at baseline and 6 months later | 
| Change in Juniper Mini Asthma Quality of Life Questionnaire (MiniAQLQ) Score | 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). | Measured at baseline and 6 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Emergency Department (ED) Visits | The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, patient responses to a question that asked During the past 6 months, how many times to you visit an emergency room of urgent care center because of your asthma? were used. | Collected at baseline and 6 months later (for the preceding 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, environmental triggers, phone-based intervention, public housing, apartments