What side effects are associated with this type of intervention?

Common treatments for COVID-19 include dexamethasone, which can cause psychiatric side effects such as depression, emotional lability, euphoria, insomnia, malaise, personality changes, and psychosis. Antiviral agents like interferon, lopinavir-ritonavir, and ribavirin generally do not interact with psychotropic drugs but can have their own side effects, such as gastrointestinal issues and liver enzyme abnormalities. Convalescent plasma (CP) is generally safe and well-tolerated but has shown limited benefit in improving clinical outcomes. The SINCERE trial focuses on social interventions like universal social needs screening, community-based service referrals, and telephonic follow-up, which do not have pharmacological side effects but aim to address secondary health effects of the pandemic.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorizations (EUAs) for several treatments for COVID-19, including antiviral drugs like remdesivir and monoclonal antibodies such as tocilizumab. These treatments target the virus directly or modulate the immune response to reduce severe outcomes. While the SINCERE trial focuses on a holistic approach involving social needs screening, community-based service referrals, and telephonic follow-up, these aspects are not typically covered by FDA drug approvals but are crucial for comprehensive patient care. The SINCERE intervention aims to address broader health disparities and improve overall health outcomes in vulnerable populations.

What other types of research exist?

Promising alternatives to the SINCERE intervention for COVID-19 patients in 2024 include: 1) Virtual clinics and telehealth consultations, which have been rapidly implemented and found to be largely acceptable and effective. 2) Mobile health technology, such as the Roadmap 2.0 app, which delivers positive psychology-based activities and facilitates remote recruitment, enrollment, and onboarding. 3) Voice-activated video communication systems, like those using consumer-grade voice assistant devices, which enhance patient-clinician communication and engagement. These alternatives leverage technology to provide efficient, scalable, and patient-centered care.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2-week, 4-week and 12-week surveys for reporting.

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.

0 / 2Eligibility criteria met

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).