- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769349
Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness
Study Overview
Status
Detailed Description
This study will aim to understand the comparative effectiveness of PB-PSH and SS-PSH on patient-centered quality of life, health care utilization, and health behaviors that will reduce COVID-19 risk by following a diverse sample of 800 PEH who are placed in PB-PSH (n = 400) or SS-PSH (n = 400) for 6 months. Barriers and facilitators will also be identified that may affect PSH implementation during the pandemic and its aftermath. The specific aims are:
Aim 1: To test the comparative effectiveness of PB-PSH and SS-PSH on COVID-19-related health behaviors (COVID-19-related personal health practices including social distancing) for PEH over time.
Aim 2: To test the comparative effectiveness of PB-PSH and SS-PSH on patient-centered quality of life (i.e., general life satisfaction; physical, mental, social, and environmental health) for PEH over time.
Aim 3: To test the comparative effectiveness of PB-PSH and SS-PSH on health care utilization health behaviors and unmet need for care for physical health, mental health, substance use disorders, for PEH over time.
Aim 4: To contextualize quantitative findings through longitudinal qualitative inquiry with 40 participants, purposively sampled from PB-PSH and SS-PSH, based on whether they are following social distancing guidelines.
Aim 5: To understand service providers, policy makers, and other stakeholders perspectives on challenges of implementing and sustaining COVID-19-related prevention practices and continuity of care in PSH.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 91303
- Los Angeles Homeless Services Authority (LAHSA)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults (aged 18+) with recent (past 12 months) lived experience with homelessness
- approved for PSH
- proficient in English
- able to provide informed consent
Exclusion Criteria:
- aged younger than 18
- not approved for PSH
- not proficient in English
- unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life Satisfaction
Time Frame: Change of Life satisfaction from baseline to 6 months
|
The NIH Toolbox item Bank v2.0 contains 10 items and will be utilized for participants to self-rate their life satisfaction
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Change of Life satisfaction from baseline to 6 months
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Quality of physical health
Time Frame: Change in quality of physical health from baseline to 6 months
|
Self-rated physical health and frequency/quantity of health-related activities will be assessed with the PROMIS Global Health Scale Version 1.2.
Scores range from 1-10, with higher scores reflecting better functioning.
|
Change in quality of physical health from baseline to 6 months
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Degree of mental health symptomatology
Time Frame: Change in symptomatology from baseline to 6 months
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The PROMIS will also be utilized to assess self-rated frequency the participant is bothered by mental health symptoms.
The lowest possible score is 8 and the highest possible score is 40.
Higher scores reflect more problematic symptomatology.
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Change in symptomatology from baseline to 6 months
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Social Isolation
Time Frame: Change in social isolation from baseline to 6 months
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The PROMIS will be utilized to assess social isolation including perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
Scores range from 6 to 40 with higher scores representing increased perceptions of isolation.
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Change in social isolation from baseline to 6 months
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Housing Environment
Time Frame: Change in satisfaction with housing environment from baseline to 6 months
|
The Housing Environment Scale will assess residential satisfaction and neighborhood quality/safety.
There are 5 subscales assessing the following: physical quality of the home, perceived quality of the neighborhood, perceived social climate in neighborhood, physical quality of home, and the physical quality of the neighborhood.
Scales contain a range of 14 to 17 items with scores that range from 14 to 85 with higher scores representing increased satisfaction with environment.
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Change in satisfaction with housing environment from baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 Prevention practices
Time Frame: Change in use of prevention practices from baseline to 6 months
|
The NIH Disaster Research Response Platform will assess participant frequency of handwashing, social distancing, and use of face covering.
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Change in use of prevention practices from baseline to 6 months
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Healthcare Utilization
Time Frame: Change in utilization from baseline to 6 months
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Participants will record their past 30-day use of physical and mental health treatment, social services, and support provided by the permanent supportive housing program
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Change in utilization from baseline to 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Benjamin Henwood, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-20-01081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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