UCSD RELINK: Connecting Adults To Supportive Services

Sponsor

Victoria D. Ojeda (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05605054

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA).

Researchers will compare coach-guided health literacy or self-study design to see if there is a difference in the access and use of healthcare in this population.

The main questions it aims to answer are:

Will this improve access and use of heath services?
Will this improve health insurance coverage and long term use of health services?

Participants will:

Meet with a health coach and service navigator during 12 sessions or meet with service navigator and complete online training over 12 weeks.
Complete surveys at different time (6months, 1 year)

Condition or Disease	Intervention/Treatment	Phase
Health Care Utilization	Behavioral: UCSD RELINK Behavioral: Self-study	N/A

Detailed Description

Health literacy refers to the skills needed to effectively access, understand, and use health resources. Inadequate health literacy annually costs the U.S. $100-$200 billion and is observed among justice involved adults (JIA)-a group of ~20 million U.S. persons who are disproportionately non-elderly and African American, Black, and Hispanic due to systemic racism and over-policing. JIA face numerous barriers in accessing healthcare which contributes to a high, lifelong burden of chronic and infectious disease. Healthcare access is defined as 1) having health insurance coverage, 2) having a regular source of care and 3) obtaining healthcare in a timely manner. Health literacy interventions for JIA are critically needed but are unavailable and NIH-funded research that is inclusive of JIA is sorely lacking. This timely study addresses these gaps. This study will implement a longitudinal mixed-methods randomized clinical trial (RCT) to assess the impact of the UCSD RELINK coach-guided health literacy intervention vs. a self-study control group on JIA's healthcare access. To achieve this aim, 300 JIA ages 18+ will be recruited in San Diego, CA and randomized 1:1 to the Treatment Group (i.e., coach-guided health literacy intervention) or the Control Group (i.e., self-study of the intervention). This study is timely and may inform health literacy interventions for JIA, policies to build health literacy among JIA in institutional and community settings, and the service delivery models for JIA. The proposed intervention has great potential for increasing health literacy among JIA and thus improving the well-being of this sizeable and underserved community. Findings from this study may also have relevance for interventions seeking to build the health literacy of other low-income communities.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

An RCT Testing a Health Literacy Intervention to Reduce Disparities in Access to Care Among Minority Justice-Involved Adults

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coach-guided In person or phone call with an assigned Health Coach for about 1 hour per week for 12 weeks to complete the Health Literacy course, and with an assigned Service Navigator for 30 minutes per week for 12 weeks to address health and social service needs.	Behavioral: UCSD RELINK UCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance
Active Comparator: Self study Self-guided printed or online version of the Health Literacy course (approximately 1 hour per week for 12 weeks) and comprehensive Service Navigation report with recommended referrals to services, providers, and contact information for service providers so that the participant can access these resources independently (i.e., without Navigator assistance).	Behavioral: Self-study Self-studying of programmatic information and list of service referrals

Arm

Intervention/Treatment

Experimental: Coach-guided

In person or phone call with an assigned Health Coach for about 1 hour per week for 12 weeks to complete the Health Literacy course, and with an assigned Service Navigator for 30 minutes per week for 12 weeks to address health and social service needs.

Behavioral: UCSD RELINK

UCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance

Active Comparator: Self study

Self-guided printed or online version of the Health Literacy course (approximately 1 hour per week for 12 weeks) and comprehensive Service Navigation report with recommended referrals to services, providers, and contact information for service providers so that the participant can access these resources independently (i.e., without Navigator assistance).

Behavioral: Self-study

Self-studying of programmatic information and list of service referrals

Outcome Measures

Primary Outcome Measures

Recent Use of Health Services [6 months]
Any healthcare use in the past 6 months (vs. never received services or received services more than 6 months ago)

Secondary Outcome Measures

Health Insurance Coverage [6 months and 12 months]
Defined as uninsured versus any insurance
Regular Source of Care [6 months and 12 months]
Presence of one (or multiple) source(s) of care identified by participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Persons, aged 18 and older
Resident of San Diego County
Not incarcerated at time of enrollment
Justice involved in the past 3 years (on parole, probation, court diverted)
Understands English
Access to a cell phone

Exclusion Criteria:

Under the age of 18
Not a resident of San Diego County
Incarcerated at enrollment
Not justice-involved within the last 3 years (i.e., not on probation or parole or was court-diverted in the past 3 years)
No access to a cell phone
Cannot provide informed consent
Does not understand English
Previously enrolled in the pilot UCSD RELINK program

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Victoria D. Ojeda
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Victoria Ojeda, PhD, MPH, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Victoria D. Ojeda, Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05605054

Other Study ID Numbers:

161903
R01MD016959

First Posted:

Nov 4, 2022

Last Update Posted:

Dec 6, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Victoria D. Ojeda, Professor, University of California, San Diego

Justice Involved Adults

Re-entry Population

Health Coaching

Service Navigation

Study Results

No Results Posted as of Dec 6, 2022