NCT04945590

Brief Summary

The purpose of this study is to objectively identify and address social determinants of health (SDOH) priorities and barriers in Latino patients who survived or are vulnerable to COVID-19, and to understand the consequences of COVID-19 survivorship in local Latino communities.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Typical duration for not_applicable covid19

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
3.4 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

June 29, 2021

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Social Determinants of Health (SDOH) Assessment Completed

    Number of families in whom SDOH were assessed at baseline and follow-up interviews.

    Through study completion, approximately 3 months

Study Arms (1)

Latino/Hispanic Virtual Intervention Program

EXPERIMENTAL

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

Behavioral: Virtual Intervention Program

Interventions

Four separate virtual individual and group interviews (via telephone or online), which will be scheduled with the help of champions and leaders of the Latino community who will collaborate as companions to improve the commitment and experience of families.

Latino/Hispanic Virtual Intervention Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Families that do not identify as Latino.
  • Those living outside Dover, Olmsted and Mower County, Minnesota.
  • Those that do not provide written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alice Gallo De Moraes, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2021

First Posted

June 30, 2021

Study Start

December 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-01