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SINCERE Intervention for COVID-19 Health Disparities (SINCERE Trial)
N/A
Recruiting
Led By Andrea Wallace, PhD
Research Sponsored by Andrea Wallace
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (> 17 years)
Be older than 18 years old
Must not have
Those living in nursing facilities, or those who are not otherwise responsible for self-care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2-week, 4-week and 12-week surveys
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if checking people's social needs, connecting them with community services, and providing ongoing support can help prevent COVID-19 spread and improve health. It focuses on those who are vulnerable to COVID-19 and face economic challenges. By understanding their needs and providing support, the goal is to help them access necessary services and improve their overall well-being.
Who is the study for?
This trial is for adults over 17 who have social needs and are willing to get help from community services after visiting certain emergency departments or COVID-19 testing sites. They must be reachable by phone or able to complete surveys online, and speak English or Spanish. It's not for those in nursing homes or unable to communicate verbally.
What is being tested?
The SINCERE intervention includes universal screening for social needs, referrals to community services, and follow-up calls. The study tests if these steps can prevent COVID-19 spread among vulnerable groups and improve health outcomes following the pandemic's socioeconomic impacts.
What are the potential side effects?
Since this trial involves non-medical interventions like screenings, referrals, and follow-ups rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience stress or discomfort during discussions of personal social needs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 17 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I live in a nursing facility or need help with daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2-week, 4-week and 12-week surveys
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2-week, 4-week and 12-week surveys
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Anxiety over 12-week time period
Change in Depression over 12-week time period
Change in Global Health over 12-week time period
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Call + Resources + Scheduled Follow-UpExperimental Treatment1 Intervention
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.
Group II: Call + Resources + SINCEREExperimental Treatment1 Intervention
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting).
Group III: Call + ResourcesActive Control1 Intervention
Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19 include antiviral drugs, corticosteroids, and supportive care. Antiviral drugs work by inhibiting the replication of the virus, reducing the viral load in the body.
Corticosteroids help by reducing inflammation and modulating the immune response, which can prevent severe complications like acute respiratory distress syndrome (ARDS). Supportive care, including oxygen therapy and mechanical ventilation, is crucial for managing symptoms and maintaining vital functions.
The SINCERE trial emphasizes the importance of addressing social determinants of health through universal social needs screening, community-based service referrals, and telephonic follow-up. This approach can improve health outcomes by ensuring that patients have access to necessary resources and support, which is essential for comprehensive COVID-19 management.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols.Key summary of German national treatment guidance for hospitalized COVID-19 patients : Key pharmacologic recommendations from a national German living guideline using an Evidence to Decision Framework (last updated 17.05.2021).
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols.Key summary of German national treatment guidance for hospitalized COVID-19 patients : Key pharmacologic recommendations from a national German living guideline using an Evidence to Decision Framework (last updated 17.05.2021).
Find a Location
Who is running the clinical trial?
Andrea WallaceLead Sponsor
2 Previous Clinical Trials
9,643 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,377,216 Total Patients Enrolled
Andrea Wallace, PhDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 17 years.I live in a nursing facility or need help with daily activities.You have completed the referral process at specific medical facilities and have indicated that you need and are willing to receive low-cost or free services from the United Way 211 community referral service.I can be contacted by phone or can complete surveys via text or email.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Call + Resources
- Group 2: Call + Resources + Scheduled Follow-Up
- Group 3: Call + Resources + SINCERE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.