NCT06042790

Brief Summary

Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. As we know that the prevalence of impairments in neurocognitive and Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of benefit to gain knowledge about the impact on the recovery trajectory for patients treated for Covid-19, and to increase the understanding of which factors that affect the HRQoL and recovery and in what way these differs between patients treated in ICU for Covid-19 and other causes respectively. This can contribute to better structures for follow-up and possibility to individualisation that better address which patients are in risk for decreased HRQoL and where benefit for the patient, health care and social economic can be achieved.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.4 years

First QC Date

September 12, 2023

Last Update Submit

September 12, 2023

Conditions

Quality of LifeIntensive Care Unit Syndrome

Keywords

Covid 19

Outcome Measures

Primary Outcomes (1)

  • HRQoL

    RAND-36

    2, 6, 12 months post ICU

Study Arms (2)

Covid-19 ICU patients

Patients with confirmed Covid-19 admitted to ICU care

non-Covid-19 patients

Non Coivd-19 patients admitted to ICU before 2020

Eligibility Criteria

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

Group I ICU patients with Covid-19 Group II ICU patients without Covid-19

You may qualify if:

  • Consecutively admitted ICU patients with a completed RAND-36 follow-up form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish Intensive Care Registry

Karlstad, Sweden

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sten Walther, PhD

    Linkoeping University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

March 1, 2020

Primary Completion

August 8, 2022

Study Completion

October 8, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)