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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04769349
Other study ID # UP-20-01081
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 29, 2021
Est. completion date August 30, 2023

Study information

Verified date April 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 563
Est. completion date August 30, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Los Angeles Homeless Services Authority (LAHSA) Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Life Satisfaction The NIH Toolbox item Bank v2.0 contains 10 items and will be utilized for participants to self-rate their life satisfaction Change of Life satisfaction from baseline to 6 months
Primary 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. Change in quality of physical health from baseline to 6 months
Primary 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. Change in symptomatology from baseline to 6 months
Primary 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. Change in social isolation from baseline to 6 months
Primary 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. Change in satisfaction with housing environment from baseline to 6 months
Secondary COVID-19 Prevention practices The NIH Disaster Research Response Platform will assess participant frequency of handwashing, social distancing, and use of face covering. Change in use of prevention practices from baseline to 6 months
Secondary 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 Change in utilization from baseline to 6 months
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