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

NCT04584450 | Completed

• 1 other identifier: GO 20/788
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dyspnea assessment

  Through study completion, an average of 1 year

• 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

Study Arms (1)

1

COVID-19 survivors.

Other: Questionnaire

Interventions

Questionnaire OTHER

data collection using questionnaire

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COVID-19 survivors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related 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):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.

  PMID: 32398306 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

  STUDY CHAIR

• Aslıhan Çakmak

  Hacettepe Üniversitesi

  PRINCIPAL INVESTIGATOR

• Esra Kınacı

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ebru Çalık-Kütükcü

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 14, 2020
• Study Start: September 2, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)