Virtual Intervention for COVID-19

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-Latino, Outside specified counties, No consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how social factors affect the health of Latino individuals who survived or are at risk of severe COVID-19. Researchers are testing a virtual intervention program designed to support these individuals and their families, focusing on their unique cultural needs. The trial seeks Latino families in Southern Minnesota who either survived a severe COVID-19 infection requiring hospitalization or are at high risk for COVID-19. Participants will join through community connections and peer recommendations.

As an unphased study, this trial offers participants the opportunity to contribute to important research that could lead to better support systems for Latino communities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual intervention program is safe?

Research has shown that virtual healthcare can be safe for patients. For example, a study with over 18,000 patients using virtual urgent care found that many completed their visits without major problems. Another study found that virtual care helped healthcare workers feel better during the pandemic, suggesting it can be useful and safe for mental health support. A review also noted that patients generally had positive experiences with virtual care during COVID-19. While some risks exist, methods can enhance the safety of virtual care. Overall, virtual healthcare, like the one in this trial, has been well-received in other situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Latino/Hispanic Virtual Intervention Program for COVID-19 because it offers a culturally tailored approach to support a community that has been disproportionately affected by the pandemic. Unlike standard treatments that focus on medical interventions like vaccines and antiviral medications, this program uses a virtual platform to provide personalized support and education in a culturally relevant way. By engaging participants in a community-based collaborative design, it aims to address not just the physical impacts of COVID-19, but also the social and emotional needs of the Latino/Hispanic community, potentially leading to improved health outcomes.

What evidence suggests that this virtual intervention program is effective for addressing social determinants of health in Latino patients affected by COVID-19?

Research shows that programs tailored for Latino communities can be effective. For example, one study found that a special outreach program increased COVID-19 testing rates among Latinx groups. Another successful method involved community health workers, known as promotoras, who shared COVID-19 prevention tips directly with the community. This approach engaged Latino communities effectively. Additionally, moving health programs online during the pandemic maintained involvement and led to positive outcomes. This trial will test a virtual intervention program specifically designed for Latino/Hispanic communities, suggesting it could address health issues related to COVID-19. ^{6 7 8 9 10}

Who Is on the Research Team?

Alice Gallo De Moraes, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

The VIDA After COVID Study is for Latino families in Southern Minnesota who have survived COVID-19 after ICU or hospital admission, their families and care partners, or those vulnerable to COVID-19. Participants must provide consent and live in Dover, Olmsted, or Mower County.

Inclusion Criteria

Study population will be identified via community partnerships and peer referrals.

Participants include Latino families in Southern Minnesota (Dover, Olmsted and Mower county, Minnesota) who survived COVID-19 after requiring ICU or hospital admission, and their families and/or their care partners, or Latino patients who are vulnerable to COVID-19, that have provided research authorization o identified via electronic health registries (following Institutional Review Board approved guidelines).

Exclusion Criteria

Only Latino families are eligible to participate.

Those that do not provide written consent.

Those living outside Dover, Olmsted and Mower County, Minnesota.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Intervention

Participants engage in a culturally tailored virtual intervention program

Approximately 3 months

Virtual sessions

Follow-up

Participants are monitored for the assessment of social determinants of health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Intervention Program

Trial Overview This study tests a Virtual Intervention Program designed to identify and address health priorities and barriers among Latinos affected by COVID-19. It aims to understand the impact of surviving COVID-19 within local Latino communities.

How Is the Trial Designed?

Group I: Latino/Hispanic Virtual Intervention Program Experimental Treatment 1 Intervention

Latino/Hispanic individuals will participate in culturally tailored virtual intervention program following a community-based collaborative design.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9204550/

Effectiveness of a COVID-19 Testing Outreach Intervention ... This cluster randomized trial assesses the effect of a culturally tailored outreach program on SARS-CoV-2 testing rates among Latinx populations in Oregon.

2. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500240X

COVID Prevention Program: Rationale and methodology of ... Promotora model to deliver tailored COVID-19 prevention strategies among Latinos. •. Real-time delivery and assessment of intervention ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05697068

Intervention to Prevent Household and Community Spread ... This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7704282/

A Self-Administered Multicomponent Web-Based Mental ... This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-022-14291-6

Impact of transitioning to virtual delivery of a cardiovascular ... This study evaluated how the online transition during the COVID-19 pandemic impacted program outcomes and promotora and participant experience ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7566682/

Virtual Urgent Care Quality and Safety in the Time of ... Results. A total of 18,278 unique adult patients completed 22,413 VUC visits. Separately, 718 patient-scheduled visits were incomplete; the majority were no- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692047/

Patient-reported experiences and outcomes of virtual care ... This review provides supportive evidence of virtual care experiences during the COVID-19 pandemic from patient and caregiver perspectives.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799726

Effect of a Virtual Home-Based Behavioral Intervention on ... In this randomized clinical trial of families with young children, weekly virtual health coaching did not detectably improve family health and resilience.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2211883724001291

Patient safety of virtual primary care: A qualitative study ... This study aimed to identify patient safety risks associated with virtual primary care, as well as strategies to mitigate these risks based on the perspectives ...

10. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1227895/full

Past the Pandemic: a virtual intervention supporting ... This virtual series showed efficacy in improving the well-being of healthcare workers during a pandemic and could serve as a model for mental health support.