Recovering From COVID-19 (OVER-COVID)

April 24, 2024 updated by: Imperial College London

Recovering From COVID-19: Community-based Remote Monitoring in COVID-19 (SARS-CoV 2) Cases: The OVER-COVID Study

Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached.

There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile.

However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps

Study Overview

Status

Withdrawn

Conditions

SARS CoV 2 Infection

Intervention / Treatment

Device: Fitbit

Study Type

Observational

Contacts and Locations

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

•Discharged from hospital with a RT-PCR SAR-CoV-2 positive swab result.

Description

INCLUSION CRITERIA

Aged 18 years or over.
Able to provide written consent.

EXCLUSION CRITERIA

Any participants that withdraw their consent.
Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
Inability to cooperate or communicate with the research team.

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
Step count Time Frame: up to 1 year	step count recorded from Fitbit devices	up to 1 year

Collaborators and Investigators

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

Sponsor

Imperial College London

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 (Estimated)

November 30, 2021

Primary Completion (Estimated)

April 8, 2024

Study Completion (Estimated)

April 8, 2024

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

21IC6755

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.