Clinical trial NCT04563858: Polish Validation 4AT Tool
Official title: Interdisciplinary Treatment Towards a Patient With Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium, Postoperative
Surgical Procedure
Keywords: Delirium
4AT Scale
Cardiac surgery
Validation
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
Collaborators: name: University of Rzeszow
name: Karolinska Institutet
First posted: 2020-09-25
Enrollment: 444
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity for the Polish version 4AT
timeFrame: third day following a surgery
measure: Reliability for the Polish version 4AT
timeFrame: third day following a surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Medical College of Rzeszow University Institute of Health Sciences
state: Warzywna Saint 1
Study officials:
affiliation: Medical College of Rzeszow University Institute of Health Sciences
name: Sabina Krupa, PhD
role: STUDY_DIRECTOR
References: