Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02054169
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2014-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)
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': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2014-01-31', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delirium', 'timeFrame': 'two hours after ED admission', 'description': 'Delirium was assessed by research assistants using the mCAM-ED. Patients with a positive delirium diagnosis were presented to a senior emergency physician (PI) who served as the reference standard. The final delirium diagnosis was based on the DSM IV criteria'}], 'secondaryOutcomes': [{'measure': 'adherence of ED staff to mCAM-ED algorithm', 'timeFrame': 'At patient discharge or transfer from ED (average 4 hours after presentation)', 'description': 'Adherence was achieved when the mCAM-ED result was documented by the ED nurses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'Delirium is common in older emergency department (ED) patients and often remains unrecognized. Existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ED setting In this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mCAM-ED).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The samples consisted of consecutive ED patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 65 or older\n\nExclusion Criteria:\n\n* patients treated in the resuscitation room\n* patients transferred or discharged within 2 hours of arrival\n* patients with insufficient proficiency in the German language\n* patients with an inability to communicate (e.g. aphasic patients)'}, 'identificationModule': {'nctId': 'NCT02054169', 'briefTitle': 'Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Pilot Study on the Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)', 'orgStudyIdInfo': {'id': 'mCAM-ED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-test group', 'description': 'All patients aged 65 or older presenting to the ED during the pre-test period'}, {'label': 'post-test period', 'description': 'All patients aged 65 or older presenting to the ED in the post-test period'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian H Nickel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christian Nickel', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}