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

NCT ID: NCT04584450

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-02

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1

COVID-19 survivors.

Questionnaire

Intervention Type OTHER

data collection using questionnaire

Interventions

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Questionnaire

data collection using questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Calik Kutukcu

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Inal-Ince

Role: STUDY_CHAIR

Hacettepe University

Gülay Sain-Güven

Role: STUDY_CHAIR

Hacettepe University

Naciye Vardar-Yagli

Role: STUDY_CHAIR

Hacettepe University

Melda Saglam

Role: STUDY_CHAIR

Hacettepe University

Lale Özışık

Role: STUDY_CHAIR

Hacettepe University

Nursel Çalık-Başaran

Role: STUDY_CHAIR

Hacettepe University

Oğuz Abdullah Uyaroğlu

Role: STUDY_CHAIR

Hacettepe University

Aslıhan Çakmak

Role: PRINCIPAL_INVESTIGATOR

Hacettepe Üniversitesi

Esra Kınacı

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ebru Çalık-Kütükcü

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.

Reference Type BACKGROUND
PMID: 32398306 (View on PubMed)

Other Identifiers

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GO 20/788

Identifier Type: -

Identifier Source: org_study_id