Long-Term Experience and Health Effects of COVID-19

June 22, 2021 updated by: Altura

A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects

The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.

Study Overview

Detailed Description

Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.

This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.

The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.

To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.

Study Type

Observational

Enrollment (Actual)

64

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
      • Mission Viejo, California, United States, 92691
        • Altura

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anyone in the USA can participate in this study that meets inclusion criteria. To ensure diversity urban, suburban and rural areas of the country will be included.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Any gender specification
  • Has consented to proceed with survey
  • Is able to complete the survey via email on a regular basis

Exclusion Criteria:

  • none

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
Longitudinal survey
Time Frame: 2 years
To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.
2 years

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Chair: Pete Fronte, MBA, Altura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

July 1, 2020

Primary Completion (Actual)

June 22, 2021

Study Completion (Actual)

June 22, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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