Back to resultsThe VIDA After COVID Study
Primary Purpose
Covid19
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Intervention Program
Sponsored by
About this trial
This is an interventional health services research trial for Covid19
Eligibility Criteria
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:
- Families that do not identify as Latino.
- Those living outside Dover, Olmsted and Mower County, Minnesota.
- Those that do not provide written consent.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Latino/Hispanic Virtual Intervention Program
Arm Description
Latino/Hispanic individuals will participate in culturally tailored virtual intervention program following a community-based collaborative design.
Outcomes
Primary Outcome Measures
Social Determinants of Health (SDOH) Assessment Completed
Number of families in whom SDOH were assessed at baseline and follow-up interviews.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04945590
Brief Title
The VIDA After COVID Study
Official Title
Virtual Intervention and Direct Assessment (VIDA) of Social Determinants of Health in Southern Minnesota Latino Communities After Coronavirus Disease 2019 (COVID-19): A Pilot Study. The VIDA After COVID Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Latino/Hispanic Virtual Intervention Program
Arm Type
Experimental
Arm Description
Latino/Hispanic individuals will participate in culturally tailored virtual intervention program following a community-based collaborative design.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Intervention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Determinants of Health (SDOH) Assessment Completed
Description
Number of families in whom SDOH were assessed at baseline and follow-up interviews.
Time Frame
Through study completion, approximately 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Families that do not identify as Latino.
Those living outside Dover, Olmsted and Mower County, Minnesota.
Those that do not provide written consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Gallo De Moraes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The VIDA After COVID Study
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