NCT05302960

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

March 29, 2022

Last Update Submit

April 24, 2024

Conditions

Keywords

monitoring, ambulatoryvital signsremote monitoring

Outcome Measures

Primary Outcomes (1)

  • Step count

    step count recorded from Fitbit devices

    up to 1 year

Interventions

FitbitDEVICE

The use of Fitbit sensors to see if activity levels can be improved to track recovery from COVID

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

March 31, 2022

Study Start

November 30, 2021

Primary Completion

April 8, 2024

Study Completion

April 8, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04