Polish Validation 4AT Tool

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.

Study Overview

• Status: Completed
• Conditions: Delirium, Postoperative; Surgical Procedure
• Intervention / Treatment: Diagnostic test: Validation

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 Type: Observational
• Enrollment (Actual): 444

Contacts and Locations

• Study Contact: Name: Sabina Krupa, PhD; Phone Number: (+48) 530 738 742; Email: sabinakrupa@o2.pl
• Study Contact Backup: Name: Dorota Ozga, PhD; Phone Number: +48 17 872 10 10; Email: gdozga@poczta.fm

Study Locations

• Poland
  • Warzywna Saint 1
    • Rzeszów, Warzywna Saint 1, Poland, 35-310
      • Medical College of Rzeszow University Institute of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac patients	Diagnostic test: Validation; Assessment of Polish version of the 4AT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Andrzej Frycz Modrzewski Krakow University
• Collaborators: Karolinska Institutet; University of Rzeszow
• Investigators: Study Director: Sabina Krupa, PhD, Medical College of Rzeszow University Institute of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 19, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Validation; Cardiac surgery; Delirium; 4AT Scale
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 9/05/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No