Delirium, PostoperativeNCT04563858
Polish Validation 4AT Tool
An observational study of Delirium, Postoperative and Surgical Procedure, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
Trial summary
Delirium is a phenomenon which affects patients with various disorders and representing various age groups. Screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Delirium, Postoperative, Surgical Procedure
- What is being tested?
- Validation
- How many people
- 444 participants
- Where
- 1 sitePoland
- Study dates
- 22 May 2020to 31 Dec 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery
Who may be able to join
- adults
- able to sign the consent form
- elective cardiac surgery
- extracorporeal circulation
Who cannot join
- unconscious patients
- diagnosed mental illness
- patient's lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical College of Rzeszow University Institute of Health Sciences
Rzeszów, Warzywna Saint 1, 35-310
About this study
Official title: Interdisciplinary Treatment Towards a Patient With Delirium
Delirium is a phenomenon which affects patients with various disorders and representing various age groups. Screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. The aim of the study is to examine the reliability and validity of the Polish version of the 4AT (Pol4-AT) in patients after cardiac surgery.
Procedure of validation:
After obtaining the author's consent, the original English version of the 4AT was separately translated by 3 centres working on the validation of the Pol4-AT (University of Rzeszów, Poland; University Hospital in England; Karolinska University, Sweden). Then, three translations were compared, to be approved by the project supervisor (Karolinska University). Any doubts arising during the comparison were consulted with the English translator. As a result, one coherent version was accepted and translated back into English. The questionnaire was distributed in a convenient sample of 20 patients to examine the validity of the face. Vague words and statements were changed, and the final version translated into Polish was created. The Pol4-AT was tested for internal consistency and reliability.
Read the detailed description
Delirium, which generally is triggered by underlying medical conditions, is an acute and fluctuating disorder associated with attention and cognitive defects, and frequently accompanied by excessive arousal and perception-related problems. Delirium may lead to a variety of complications, e.g. cognitive impairments. Development of delirium is promoted by both anaesthesia and pain. Patients subjected to cardiac surgeries are at risk of delirium due to such factors as extracorporeal circulation applied during the intervention and various cardiovascular complications. Rapid identification of the problem may help eliminate avoidable complications which can be prevented at an early stage.
- Conditions
- Delirium, Postoperative, Surgical Procedure
- Being tested
- Validation
- Keywords
- Delirium, 4AT Scale, Cardiac surgery, Validation
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValidationDiagnostic test
Assessment of Polish version of the 4AT
| Study group | Role | What they receive |
|---|---|---|
| Cardiac patients | Not described Receives: Diagnostic Test: Validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity for the Polish version 4AT
The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.
A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.
Measured: third day following a surgery
Reliability for the Polish version 4AT
The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.
A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.
Measured: third day following a surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 May 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rzeszow, Karolinska Institutet
- Responsible party
- Principal investigator, Lucyna Tomaszek, Andrzej Frycz Modrzewski Krakow University
- Investigators
- Sabina Krupa, PhD, Study director, Medical College of Rzeszow University Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563858
- Sponsor's protocol ID
- 9/05/2020
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Treatment Towards a Patient With Delirium
- ClinicalTrials.gov ID
- NCT04563858
- Acronym / sponsor ID
- 9/05/2020
- Conditions
- Delirium, Postoperative, Surgical Procedure
- Keywords
- Delirium, 4AT Scale, Cardiac surgery, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Collaborators
- University of Rzeszow, Karolinska Institutet
- Study start
- 22 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Sep 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.
Delirium is a phenomenon which affects patients with various disorders and representing various age groups. Screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. The aim of the study is to examine the reliability and validity of the Polish version of the 4AT (Pol4-AT) in patients after cardiac surgery.
Procedure of validation:
After obtaining the author's consent, the original English version of the 4AT was separately translated by 3 centres working on the validation of the Pol4-AT (University of Rzeszów, Poland; University Hospital in England; Karolinska University, Sweden). Then, three translations were compared, to be approved by the project supervisor (Karolinska University). Any doubts arising during the comparison were consulted with the English translator. As a result, one coherent version was accepted and translated back into English. The questionnaire was distributed in a convenient sample of 20 patients to examine the validity of the face. Vague words and statements were changed, and the final version translated into Polish was created. The Pol4-AT was tested for internal consistency and reliability.
Detailed description
Delirium, which generally is triggered by underlying medical conditions, is an acute and fluctuating disorder associated with attention and cognitive defects, and frequently accompanied by excessive arousal and perception-related problems. Delirium may lead to a variety of complications, e.g. cognitive impairments. Development of delirium is promoted by both anaesthesia and pain. Patients subjected to cardiac surgeries are at risk of delirium due to such factors as extracorporeal circulation applied during the intervention and various cardiovascular complications. Rapid identification of the problem may help eliminate avoidable complications which can be prevented at an early stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac patients | – | Diagnostic Test: Validation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery
Key inclusion criteria (4 listed)
- adults
- able to sign the consent form
- elective cardiac surgery
- extracorporeal circulation
Key exclusion criteria (3 listed)
- unconscious patients
- diagnosed mental illness
- patient's lack of consent to participate in the study
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 |
|---|---|---|
| ValidationAssessment of Polish version of the 4AT | Diagnostic test | Cardiac patients |
Primary outcome
Validity for the Polish version 4AT
Time frame: third day following a surgery
The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course. A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.
Reliability for the Polish version 4AT
Time frame: third day following a surgery
The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course. A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.
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 6 Feb 2024.
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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.
Sabina Krupa, PhD study director
Medical College of Rzeszow University Institute of Health Sciences
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 Delirium, Postoperative and Surgical Procedure, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
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 4 inclusion and 3 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 6 Feb 2024. 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 Poland. 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?
Validity for the Polish version 4AT (time frame: third day following a surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024.