Clinical trial NCT04584450: Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale
Official title: Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 survivors

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.


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.

Primary outcomes:
measure: Post-COVID-19 Functional Status Scale (Turkish version)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Dyspnea assessment
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of daily living activities
timeFrame: Through study completion, an average of 1 year
measure: Assessment of the structural validity of the Post-COVID-19 Functional Status Scale
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Gülay Sain-Güven
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Melda Saglam
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Lale Özışık
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Nursel Çalık-Başaran
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Oğuz Abdullah Uyaroğlu
role: STUDY_CHAIR
affiliation: Hacettepe Üniversitesi
name: Aslıhan Çakmak
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Esra Kınacı
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Çalık-Kütükcü
role: STUDY_DIRECTOR
References:
citation: 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.