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Clinical Trials/NCT05228886
NCT05228886
Recruiting
N/A

Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities

Andrea Wallace1 site in 1 country1,500 target enrollmentSeptember 27, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID-19
Sponsor
Andrea Wallace
Enrollment
1500
Locations
1
Primary Endpoint
Change in Anxiety over 12-week time period
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2021
End Date
March 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Andrea Wallace

Professor

University of Utah

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Anxiety over 12-week time period

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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