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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COVID-19 survivors

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; COVID-19 survivors.	Other: Questionnaire; data collection using questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-COVID-19 Functional Status Scale (Turkish version)	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.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea assessment	Dyspnea will be assessed by the Modified Medical Research Council (MMRC) dyspnea scale. Individuals are asked to choose the expression that best describes their dyspnea level. Scoring in MMRC varies between 0-4 points. "0 points" means that there is no dyspnea; "4 points" indicates that there is a perception of dyspnea during basic daily life activities such as dressing.	Through study completion, an average of 1 year
Evaluation of daily living activities	The Barthel index was developed by Mahoney and Barthel in 1965. It is an index that is simple, understandable and includes all parameters of daily life activities. Its Turkish validity and reliability were made by Küçükdeveci et al. It consists of 10 sub-headings: eating, bathing, self-care, dressing, bladder control, bowel control, toilet use, chair / bed transfer, mobility, and use of stairs. Its scoring ranges from 0 to 100.	Through study completion, an average of 1 year
Assessment of the structural validity of the Post-COVID-19 Functional Status Scale	The London Chest Activities of Daily Living Scale, developed by Garrod et al., will be used to evaluate the structural validity of the Post-COVID-19 Functional Status Scale. This questionnaire consists of 15 items and four components: personal care (4 items), housework (6 items), physical (2 items) and leisure (3 items). Each item is scored between 0 and 5. High scores show that the limitation in daily living activities is greater. The total score can reach 75 at most. The validity and reliability study of the questionnaire for the Turkish population has been conducted.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Deniz Inal-Ince, Hacettepe University; Study Chair: Gülay Sain-Güven, Hacettepe University; Study Chair: Naciye Vardar-Yagli, Hacettepe University; Study Chair: Melda Saglam, Hacettepe University; Study Chair: Lale Özışık, Hacettepe University; Study Chair: Nursel Çalık-Başaran, Hacettepe University; Study Chair: Oğuz Abdullah Uyaroğlu, Hacettepe University; Principal Investigator: Aslıhan Çakmak, Hacettepe Universitesi; Principal Investigator: Esra Kınacı, Hacettepe University; Study Director: Ebru Çalık-Kütükcü, Hacettepe University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GO 20/788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No