Clinical trial NCT05345080: Houston "Breathe Easy" Healthy Homes-Based Model for Multifamily Rental Communities
Official title: Phase 2 of the Houston "Breathe Easy" Healthy Homes-Based Model for Multifamily Rental Communities: Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Respiratory Tract Disease
Lung Diseases
Sinusitis, Chronic
Keywords: asthma
environmental triggers
phone-based intervention
public housing
apartments
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Harris County Hospital District
name: The University of Texas Health Science Center, Houston
name: Oregon State University
First posted: 2022-04-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Asthma Control Test (ACT) Score
timeFrame: Measured at baseline and 6 months later
measure: Change in Juniper Mini Asthma Quality of Life Questionnaire (MiniAQLQ) Score
timeFrame: Measured at baseline and 6 months later
Secondary outcomes:
measure: Change in Emergency Department (ED) Visits
timeFrame: Collected at baseline and 6 months later (for the preceding 6 months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Winifred J Hamilton, PhD, SM
role: PRINCIPAL_INVESTIGATOR
References: