NCT04563858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

September 19, 2020

Last Update Submit

February 4, 2024

Conditions

Delirium, PostoperativeSurgical Procedure

Keywords

Delirium4AT ScaleCardiac surgeryValidation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Cardiac patients

Diagnostic Test: Validation

Interventions

ValidationDIAGNOSTIC_TEST

Assessment of Polish version of the 4AT

Cardiac patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery

You may qualify if:

  • adults
  • able to sign the consent form
  • elective cardiac surgery
  • extracorporeal circulation

You may not qualify if:

  • unconscious patients
  • diagnosed mental illness
  • patient's lack of consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Rzeszow University Institute of Health Sciences

Rzeszów, Warzywna Saint 1, 35-310, Poland

Location

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Sabina Krupa, PhD

    Medical College of Rzeszow University Institute of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2020

First Posted

September 25, 2020

Study Start

May 22, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

PL(1)