You and Me Healthy (YMH)

December 19, 2023 updated by: Duke University

You and Me Healthy Registry Study

The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about COVID-19 and other conditions.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus responsible for the COVID-19 pandemic. In the United States (US) up until January 2022, > 60 million people have been infected with the SARS-CoV-2 virus and >800,000 died, with infections and deaths disproportionally affecting populations that have been historically marginalized1. Wide disparities also persist by race/ethnicity and age with COVID-19 testing and vaccine uptake related to social and structural factors, resulting in adverse health consequences.

As public health measures have scaled up, mitigation strategies are increasingly being considered to reduce community spread of infection. These measures include rapid-result at-home tests, protective measures (masking, social distancing, increased hygiene), treatments, and contact-tracing and isolation. As the pandemic evolves, new discoveries, technologies, and strategies to combat COVID-19 are being implemented with limited backing of research data. To address this continued unmet public health need, the You and Me Healthy registry is being created to engage community members and serve as a way to provide and collect information from all people who are interested in engaging in upcoming research studies, including those related to COVID-19.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Merced, California, United States, 95340
        • Merced County
    • North Carolina
      • Greenville, North Carolina, United States, 27705
        • Greenville Pitt County
    • Tennessee
      • Chattanooga, Tennessee, United States, 37341
        • Hamilton County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The You and Me Healthy Registry will include children and adults currently living across the United States.

Description

Inclusion Criteria:

  • Currently residing in the United States
  • Age ≥ 2 (for minors, parents/legal guardian will be the primary point of contact)
  • Able to speak and read in the language used in the surveys/assessments available

Exclusion Criteria:

There are no specific exclusion criteria for this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants enrolled in the Virtual Community
Time Frame: Through study completion; 5 years
Create a virtual community of people in the United States interested in engaging in upcoming research studies, including those related to COVID-19; By asking them to sign -up and join the registry- they provide their email address and through that they will receive information on upcoming research and information on health issues occurring in their community.
Through study completion; 5 years
Number of participants included in the Dataset
Time Frame: Through study completion; 5 years
Create a dataset of health-related measurements, risk factors, and outcomes for future; analysis and in support of upcoming research studies; through collecting survey responses via questioners.
Through study completion; 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christoph Hornik, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Estimated)

September 8, 2024

Study Completion (Estimated)

September 8, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00110716

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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