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Long-Term Experience and Health Effects of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477902
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Altura

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Corona Virus Infection Quality of Life Risk Reduction Other: none - observational

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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: none - observational
    online survey


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477902


Contacts
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Contact: Study Support 949-716-6100 support@alturastudies.com

Locations
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United States, California
Altura Recruiting
Mission Viejo, California, United States, 92691
Contact: Study Support    949-716-6100    support@alturastudies.com   
Principal Investigator: Michael Wukelic, MD         
Sponsors and Collaborators
Altura
Investigators
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Study Chair: Pete Fronte, MBA Altura
Additional Information:
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Responsible Party: Altura
ClinicalTrials.gov Identifier: NCT04477902    
Other Study ID Numbers: altcovid-192020
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Altura:
corona virus
coronavirus
covid-19
covid19
SARS-CoV-2
infection
household
transmission
vaccine
clinical trials
online
Altura
outpatient
telemedicine
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases