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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584450
• Other study ID #: GO 20/788
• Status: Completed
• Start date: September 2, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Questionnaire
data collection using questionnaire

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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). pii: 2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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