The SINCERE Intervention to Address COVID-19 Health Disparities

Not Applicable

Recruiting

• Conditions: Social Determinants of Health; COVID-19; Vulnerable Populations

• Registration Number: NCT05228886
• Lead Sponsor: Andrea Wallace

Brief Summary

The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-27
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Adult (> 17 years)
• English or Spanish speaking
• Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
• Able to be reached by phone during the intervention OR able to complete surveys sent by text or email

Exclusion Criteria

• Those unable to communicate verbally
• Those living in nursing facilities, or those who are not otherwise responsible for self-care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Anxiety over 12-week time period	Baseline, 2-week, 4-week and 12-week surveys	Standardized PROMIS Anxiety- Short Form 7a. 7 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Change in Global Health over 12-week time period	Baseline, 2-week, 4-week and 12-week surveys	Standardized PROMIS v1.2 Global Health. 10 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating lower severity. The outcome variable will be PROMIS v1.2 Global Health with Time included as a variable in the model.
Change in Depression over 12-week time period	Baseline, 2-week, 4-week and 12-week surveys	Standardized PROMIS Depression - Short Form 8b. 8 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States