NCT04912778

Brief Summary

The aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

June 2, 2021

Last Update Submit

September 22, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Functional status

    Post-COVID-19 functional status is evaluated by the Post-COVID-19 Functional Status Scale.

    Up to 18 months after infection with Covid-19.

  • Health-related Quality of life

    The EuroQol with five dimensions and three levels is used to evaluate health-related quality of life.

    Up to 18 months after infection with Covid-19.

  • Symptoms of central sensitisation

    Symptoms of central sensitisation are assessed by the Central Sensitization Inventory.

    Up to 18 months after infection with Covid-19.

Study Arms (1)

Persons who had a covid-19 infection.

Male and female adults who were previously infected with covid-19.

Other: Filling in an online survey

Interventions

Patients are asked to fill in an online survey regarding functional status, quality of life and symptoms of central sensitisation.

Persons who had a covid-19 infection.

Eligibility Criteria

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

In this study male and female adults who were previously infected with covid-19 will be eligible to complete the survey. No specific criteria will be imposed regarding the time frame after infection.

You may qualify if:

  • male and female adults who were previously infected with covid-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Related Publications (1)

  • Moens M, Duarte RV, De Smedt A, Putman K, Callens J, Billot M, Roulaud M, Rigoard P, Goudman L. Health-related quality of life in persons post-COVID-19 infection in comparison to normative controls and chronic pain patients. Front Public Health. 2022 Oct 20;10:991572. doi: 10.3389/fpubh.2022.991572. eCollection 2022.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 3, 2021

Study Start

June 4, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations