Skip to main content
Clinical Trials/NCT04584450
NCT04584450
Completed
Not Applicable

Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale

Hacettepe University1 site in 1 country100 target enrollmentSeptember 2, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Hacettepe University
Enrollment
100
Locations
1
Primary Endpoint
Post-COVID-19 Functional Status Scale (Turkish version)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The new type of Coronavirus (SARS-CoV-2) epidemic puts great pressure on health systems around the world. A large number of people are hospitalized in intensive care units due to acute respiratory distress syndrome due to SARS-CoV-2. Common symptoms seen with SARS-CoV-2 include fever, cough, and dyspnea, as well as pneumonia, severe acute respiratory distress syndrome, renal failure, and even death. Many patients develop mild to moderate disease without pneumonia. The respiratory condition of some patients continues to worsen gradually and develop acute respiratory distress syndrome, which usually requires mechanical ventilation support.

Exercise capacity and health status of individuals who survived severe acute respiratory distress syndrome are lower than the general population. Persistent physical, cognitive, and psychosocial disorders can be seen in people who have survived acute respiratory distress syndrome.

Given the clinical and radiological heterogeneity of COVID-19, it is important to have a simple tool for the disease to monitor the course of symptoms and the impact of symptoms on patients' functional status.

Klok FA et al. developed the Post-COVID-19 Functional Status Scale (PCFS). PCFS can be evaluated for functional sequelae after discharge from the hospital, at 4 and 8 weeks after discharge, to directly monitor recovery, and at 6 months. The aim of this study is to investigate the validity and reliability of PCFS in Turkish population. Research permission to investigate the validity and reliability of PCFS in the Turkish population was obtained from the developer of the PCFS.

Registry
clinicaltrials.gov
Start Date
September 2, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ebru Calik Kutukcu

Assoc. Prof.

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • clinically stable,
  • being 18 years of age or older,
  • having education level at least primary school,
  • whose local language is Turkish,
  • being discharged after COVID-19
  • giving consent on a voluntary basis.

Exclusion Criteria

  • having an unstable clinical condition,
  • being stayed in intensive care,
  • having severe neuromuscular and musculoskeletal problems,
  • not being able to cooperate to fill questionnaires,
  • having a cognitive problem,
  • not being able to read,
  • not being willing to participate in the study.

Outcomes

Primary Outcomes

Post-COVID-19 Functional Status Scale (Turkish version)

Time Frame: Through study completion, an average of 1 year

It has been proposed as a tool to measure the full spectrum of functional outcomes following COVID-19. Post-COVID-19 Functional Status scale was reported to be used to monitor functional status. Scoring varies between 0-4. The expression 0 in PCFS indicates that there is no functional limitation. Grade 4 describes patients with severe functional limitations that require assistance with activities of daily living.

Secondary Outcomes

  • Evaluation of daily living activities(Through study completion, an average of 1 year)
  • Assessment of the structural validity of the Post-COVID-19 Functional Status Scale(Through study completion, an average of 1 year)
  • Dyspnea assessment(Through study completion, an average of 1 year)

Study Sites (1)

Loading locations...

Similar Trials