HousingNCT04769349
Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness
An observational study of Housing and Covid19, run by University of Southern California at 1 site in United States.
Trial summary
This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Housing, Covid19, Mental Health
- How many people
- 563 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2021to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 800 adults experiencing homelessness who have been approved for permanent supportive housing (PSH) in Los Angeles
Who may be able to join
- adults (aged 18+) with recent (past 12 months) lived experience with homelessness
- approved for PSH
- proficient in English
- able to provide informed consent
Who cannot join
- aged younger than 18
- not approved for PSH
- not proficient in English
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Homeless Services Authority (LAHSA)
Los Angeles, California, 91303
About this study
This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). In a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, COVID-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. A sub-sample of 40 participants living in both PB-PSH and SS-PSH will be qualitatively interviewed longitudinally to help contextualize quantitative findings. Focus groups will also be conducted with providers of PSH and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining COVID-19 related prevention practices while maintaining a continuity of care.
Read the 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.
- Conditions
- Housing, Covid19, Mental Health, Physical Health, Social Interaction, Healthcare
- Medical subject headings
- COVID-19, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Satisfaction
The NIH Toolbox item Bank v2.0 contains 10 items and will be utilized for participants to self-rate their life satisfaction
Measured: Change of Life satisfaction from baseline to 6 months
Quality of physical health
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.
Measured: Change in quality of physical health from baseline to 6 months
Degree of mental health symptomatology
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.
Measured: Change in symptomatology from baseline to 6 months
Social Isolation
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.
Measured: Change in social isolation from baseline to 6 months
Housing Environment
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.
Measured: Change in satisfaction with housing environment from baseline to 6 months
Secondary outcomes (2)
COVID-19 Prevention practices
The NIH Disaster Research Response Platform will assess participant frequency of handwashing, social distancing, and use of face covering.
Measured: Change in use of prevention practices from baseline to 6 months
Healthcare Utilization
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
Measured: Change in utilization from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start29 Jan 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HousingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Benjamin F. Henwood, University of Southern California
- Investigators
- Benjamin Henwood, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769349
- Sponsor's protocol ID
- UP-20-01081
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henwood BF, Kuhn R, Padwa H, Ijadi-Maghsoodi R, Corletto G, Lawton A, Chien J, Bluthenthal R, Cousineau MR, Chinchilla M, Tran Smith B, Vickery KD, Harris T, Patanwala M, Akabike W, Gelberg L. Investigating the Comparative Effectiveness of Place-Based and Scatter-Site Permanent Supportive Housing for People Experiencing Homelessness During the COVID-19 Pandemic: Protocols for a Mixed Methods, Prospective Longitudinal Study. JMIR Res Protoc. 2023 Apr 28;12:e46782. doi: 10.2196/46782.
PubMed 37115590
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT04769349
- Acronym / sponsor ID
- UP-20-01081
- Conditions
- Housing, Covid19, Mental Health, Physical Health, Social Interaction, Healthcare
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 563 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). In a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, COVID-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. A sub-sample of 40 participants living in both PB-PSH and SS-PSH will be qualitatively interviewed longitudinally to help contextualize quantitative findings. Focus groups will also be conducted with providers of PSH and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining COVID-19 related prevention practices while maintaining a continuity of care.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 800 adults experiencing homelessness who have been approved for permanent supportive housing (PSH) in Los Angeles
Key inclusion criteria (4 listed)
- adults (aged 18+) with recent (past 12 months) lived experience with homelessness
- approved for PSH
- proficient in English
- able to provide informed consent
Key exclusion criteria (4 listed)
- aged younger than 18
- not approved for PSH
- not proficient in English
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Degree of mental health symptomatology
Time frame: Change in symptomatology from baseline to 6 months
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.
Social Isolation
Time frame: Change in social isolation from baseline to 6 months
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.
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.
2 secondary outcomes
COVID-19 Prevention practices
Time frame: Change in use of prevention practices from baseline to 6 months
Healthcare Utilization
Time frame: Change in utilization from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 37115590Henwood BF, Kuhn R, Padwa H, Ijadi-Maghsoodi R, Corletto G, Lawton A, Chien J, Bluthenthal R, Cousineau MR, Chinchilla M, Tran Smith B, Vickery KD, Harris T, Patanwala M, Akabike W, Gelberg L. Investigating the Comparative Effectiveness of Place-Based and Scatter-Site Permanent Supportive Housing for People Experiencing Homelessness During the COVID-19 Pandemic: Protocols for a Mixed Methods, Prospective Longitudinal Study. JMIR Res Protoc. 2023 Apr 28;12:e46782. doi: 10.2196/46782.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Henwood principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Housing and Covid19, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Satisfaction (time frame: Change of Life satisfaction from baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.