Covid19NCT04584450
Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale
An observational study of Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COVID-19 survivors
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
data collection using questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 1 | COVID-19 survivors. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start2 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Deniz Inal-Ince, Study chair, Hacettepe UniversityGülay Sain-Güven, Study chair, Hacettepe UniversityNaciye Vardar-Yagli, Study chair, Hacettepe UniversityMelda Saglam, Study chair, Hacettepe UniversityLale Özışık, Study chair, Hacettepe UniversityNursel Çalık-Başaran, Study chair, Hacettepe UniversityOğuz Abdullah Uyaroğlu, Study chair, Hacettepe UniversityAslıhan Çakmak, Principal investigator, Hacettepe Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584450
- Sponsor's protocol ID
- GO 20/788
- Status last verified
- Jan 2021
- First submitted
- 9 Oct 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32398306
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale
- ClinicalTrials.gov ID
- NCT04584450
- Acronym / sponsor ID
- GO 20/788
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: QuestionnaireCOVID-19 survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 survivors
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairedata collection using questionnaire | Other | 1 |
Primary outcome
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.
3 secondary outcomes
Dyspnea assessment
Time frame: Through study completion, an average of 1 year
Evaluation of daily living activities
Time frame: Through study completion, an average of 1 year
Assessment of the structural validity of the Post-COVID-19 Functional Status Scale
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 32398306Klok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Inal-Ince study chair
Hacettepe University
Gülay Sain-Güven study chair
Hacettepe University
Naciye Vardar-Yagli study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-COVID-19 Functional Status Scale (Turkish version) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.