Polish Validation 4AT Tool

Delirium, Postoperative Clinical Trial

Official title:

Interdisciplinary Treatment Towards a Patient With Delirium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563858
• Other study ID #: 9/05/2020
• Status: Completed
• Start date: May 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Andrzej Frycz Modrzewski Krakow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• adults

• able to sign the consent form

• elective cardiac surgery

• extracorporeal circulation

Exclusion Criteria:

• unconscious patients

• diagnosed mental illness

• patient's lack of consent to participate in the study

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative
• Surgical Procedure

Intervention

Diagnostic Test:
• Validation
Assessment of Polish version of the 4AT

Locations

Country	Name	City	State
Poland	Medical College of Rzeszow University Institute of Health Sciences	Rzeszów	Warzywna Saint 1

Sponsors (3)

Lead Sponsor	Collaborator
Andrzej Frycz Modrzewski Krakow University	Karolinska Institutet, University of Rzeszow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	third day following a surgery
Primary	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.	third day following a surgery