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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Diseases; Asthma; Respiratory Tract Disease; Sinusitis, Chronic
• Intervention / Treatment: Behavioral: Exposure-Reduction Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure-Reduction Intervention Group; 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; 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.
No Intervention: Phone-Call-Only Control Group; 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?

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)

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: The University of Texas Health Science Center, Houston; Harris County Hospital District; Oregon State University
• Investigators: Principal Investigator: Winifred J Hamilton, PhD, SM, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: asthma; public housing; environmental triggers; phone-based intervention; apartments
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Lung Diseases; Sinusitis; Respiratory Tract Diseases
• Other Study ID Numbers: H-46145; TXHHU0043-18 (Other Grant/Funding Number: U.S. Department of Housing & Urban Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant lab results and a progress note are posted in the participant's Harris Health electronic medical record (EMR). Low enrollment limits the usefulness of data sharing with other researchers at the individual level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No