Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-21 @ 6:00 AM
Study NCT ID:
NCT00921466
Status:
UNKNOWN
Last Update Posted:
2009-06-16
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-15', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Evaluate the clinical content of the e-SSRS-IVR'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rogershospital.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with respect to 1.the intent of the instrument (assess face and content validity), 2. system validation with respect to programming integrity, 3. implementation feasibility in clinical ill and healthy patient populations, and 4. criterion/predictive validity to discriminate patient population with known clinical status differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects will be recruited from a single clinical site (Rogers Memorial Hospital, Milwaukee WI). Half of the subjects will be recruited through public advertisement for Rogers Hospital employees and the other half will be recruited from recent inpatient psychiatric admissions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking adults, able/willing to read and provide written consent\n\nExclusion Criteria:\n\n* Dementia, delirium, psychosis or deafness.\n* Control subjects will be excluded for any MINI lifetime MDD or dysthymia diagnosis of a DSM-IV disorder except for specific phobia or dependence on nicotine and caffeine.\n* Inpatients not admitted with suicidal ideations'}, 'identificationModule': {'nctId': 'NCT00921466', 'acronym': 'e-SSRS-IVR', 'briefTitle': 'Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR', 'organization': {'class': 'OTHER', 'fullName': 'Rogers Center for Research & Training, Inc.'}, 'officialTitle': 'Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR', 'orgStudyIdInfo': {'id': '113235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital Patients/Hospital Employees'}, {'label': 'Hospital employees', 'description': 'A group of 10 hospital employees used as baseline'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53227', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Rogers Center for Research and Training, Inc', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'John H Greist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rogers center for Research and Training, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rogers Center for Research & Training, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr John Greist', 'oldOrganization': 'Rogers Center for Research and Training, Inc'}}}}