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

NCT05345080 | Unknown

• 2 other identifiers: H-46145TXHHU0043-18
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

asthma; environmental triggers; phone-based intervention; public housing; apartments

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Emergency Department (ED) Visits

  Collected at baseline and 6 months later (for the preceding 6 months)

Study Arms (2)

Exposure-Reduction Intervention Group

EXPERIMENTAL

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

Phone-Call-Only Control Group

NO INTERVENTION

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.

Interventions

Exposure-Reduction Intervention 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.

Exposure-Reduction Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Harris County Hospital District: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Oregon State University: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Asthma; Respiratory Tract Diseases; Lung Diseases; Sinusitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease

Study Officials

• Winifred J Hamilton, PhD, SM

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: August 27, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)