Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-28 @ 6:31 PM
Study NCT ID:
NCT04589767
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-10-10', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inter-evaluator agreement', 'timeFrame': '1 hour during PICU stay', 'description': 'CAPD evaluation by two operators'}, {'measure': 'intra-evaluator agreement', 'timeFrame': '2 minutes during PICU stay', 'description': 'CAPD evaluation by two operators'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['delirium', 'monitoring'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': '70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).', 'detailedDescription': 'The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic.\n\nIn this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).\n\nThe score will be recorded in a data collection card, all the cards will be collected and then analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children admitted in PICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PICU admission\n* Comfort Behavioral Score \\> 11\n\nExclusion Criteria:\n\n* use of neuromuscular blocking agents at the moment of CAPD evaluation\n* Comfort Behavioral Score \\< 11'}, 'identificationModule': {'nctId': 'NCT04589767', 'briefTitle': 'Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera di Padova'}, 'officialTitle': 'Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language', 'orgStudyIdInfo': {'id': '4792/AO/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children admitted in PICU', 'description': 'children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later.', 'interventionNames': ['Behavioral: CAPD scale']}], 'interventions': [{'name': 'CAPD scale', 'type': 'BEHAVIORAL', 'description': 'Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later', 'armGroupLabels': ['children admitted in PICU']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Padua', 'country': 'Italy', 'facility': 'PICU University Hospital of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'angela amigoni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'angela amigoni', 'investigatorAffiliation': 'Azienda Ospedaliera di Padova'}}}}