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

Primary Purpose

Asthma, Respiratory Tract Disease, Lung Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure-Reduction Intervention
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, environmental triggers, phone-based intervention, public housing, apartments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposure-Reduction Intervention Group

Phone-Call-Only Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2022
Last Updated
June 2, 2022
Sponsor
Baylor College of Medicine
Collaborators
Harris County Hospital District, The University of Texas Health Science Center, Houston, Oregon State University
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1. Study Identification

Unique Protocol Identification Number
NCT05345080
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Harris County Hospital District, The University of Texas Health Science Center, Houston, Oregon State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Respiratory Tract Disease, Lung Diseases, Sinusitis, Chronic
Keywords
asthma, environmental triggers, phone-based intervention, public housing, apartments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure-Reduction Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Phone-Call-Only Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure-Reduction Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Asthma Control Test (ACT) Score
Description
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.
Time Frame
Measured at baseline and 6 months later
Title
Change in Juniper Mini Asthma Quality of Life Questionnaire (MiniAQLQ) Score
Description
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).
Time Frame
Measured at baseline and 6 months later
Secondary Outcome Measure Information:
Title
Change in Emergency Department (ED) Visits
Description
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.
Time Frame
Collected at baseline and 6 months later (for the preceding 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winifred J Hamilton, PhD, SM
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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

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