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NCT Number: NCT04584450

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

data collection using questionnaire

Primary outcomes

  1. Post-COVID-19 Functional Status Scale (Turkish version)

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Dyspnea assessment

    Time frame: Through study completion, an average of 1 year

    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.

  2. Evaluation of daily living activities

    Time frame: Through study completion, an average of 1 year

    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.

  3. Assessment of the structural validity of the Post-COVID-19 Functional Status Scale

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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