Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT04563858
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polish Validation 4AT Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-04', 'studyFirstSubmitDate': '2020-09-19', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity for the Polish version 4AT', 'timeFrame': 'third day following a surgery', 'description': 'The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.\n\nA 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.'}, {'measure': 'Reliability for the Polish version 4AT', 'timeFrame': 'third day following a surgery', 'description': 'The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', '4AT Scale', 'Cardiac surgery', 'Validation'], 'conditions': ['Delirium, Postoperative', 'Surgical Procedure']}, 'descriptionModule': {'briefSummary': "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.\n\nProcedure of validation:\n\nAfter 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adults\n* able to sign the consent form\n* elective cardiac surgery\n* extracorporeal circulation\n\nExclusion Criteria:\n\n* unconscious patients\n* diagnosed mental illness\n* patient's lack of consent to participate in the study"}, 'identificationModule': {'nctId': 'NCT04563858', 'briefTitle': 'Polish Validation 4AT Tool', 'organization': {'class': 'OTHER', 'fullName': 'Andrzej Frycz Modrzewski Krakow University'}, 'officialTitle': 'Interdisciplinary Treatment Towards a Patient With Delirium', 'orgStudyIdInfo': {'id': '9/05/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac patients', 'interventionNames': ['Diagnostic Test: Validation']}], 'interventions': [{'name': 'Validation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of Polish version of the 4AT', 'armGroupLabels': ['Cardiac patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35-310', 'city': 'Rzeszów', 'state': 'Warzywna Saint 1', 'country': 'Poland', 'facility': 'Medical College of Rzeszow University Institute of Health Sciences', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}], 'overallOfficials': [{'name': 'Sabina Krupa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical College of Rzeszow University Institute of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrzej Frycz Modrzewski Krakow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rzeszow', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lucyna Tomaszek', 'investigatorAffiliation': 'Andrzej Frycz Modrzewski Krakow University'}}}}