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

NCT ID: NCT05345080

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2022-06-30

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure-Reduction Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harris County Hospital District

OTHER_GOV

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Winifred J. Hamilton, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Winifred J Hamilton, PhD, SM

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

TXHHU0043-18

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-46145

Identifier Type: -

Identifier Source: org_study_id