Polish Validation 4AT Tool | NCT04563858

Studies
Polish Validation 4AT Tool

NCT04563858

Sponsor

Andrzej Frycz Modrzewski Krakow University

Status

Completed

Last Update Posted

Feb 6, 2024Actual

Enrollment

444Actual

Phase

Not provided

Conditions

Delirium, Postoperative
Surgical Procedure

Interventions

Validation

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2020Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Sep 19, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2024

Last Update Posted Date

Feb 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lucyna Tomaszek, Principal Investigator, Andrzej Frycz Modrzewski Krakow UniversityPrincipal Investigator

Lead Sponsor

Andrzej Frycz Modrzewski Krakow UniversityOTHER

Collaborators

Name	Class
University of Rzeszow	OTHER
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

444Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac patients			Diagnostic Test: Validation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Validation	Diagnostic Test	Assessment of Polish version of the 4AT	Cardiac patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sabina Krupa, PhD	Medical College of Rzeszow University Institute of Health Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical College of Rzeszow University Institute of Health Sciences		Rzeszów	Warzywna Saint 1	35-310	Poland

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided