Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-27 @ 4:40 AM
Study NCT ID:
NCT01869660
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2013-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making for Patients With First-admission Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2013-05-27', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Within 7days before the date of discharge'}], 'secondaryOutcomes': [{'measure': 'Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)', 'timeFrame': 'Within 7days before the date of discharge'}, {'measure': 'Treatment continuation as measured by the rate of outpatient attendance during the 30 days', 'timeFrame': '6 months after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['First hospitalization'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '28166757', 'type': 'DERIVED', 'citation': 'Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial. BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.'}, {'pmid': '24725910', 'type': 'DERIVED', 'citation': 'Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial. BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to an acute care psychiatric ward.\n* Diagnosed with schizophrenia (ICD-10 codes: F20-F29)\n* Aged 16 to 65 years old at admission\n* No prior experience of psychiatric admission (first-admission)\n\nExclusion Criteria:\n\n* Diagnosed with moderate to severe mental retardation\n* Diagnosed with organic mental disorders (ICD10 codes: F00-F09)\n* Having poor Japanese language skill\n* Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.'}, 'identificationModule': {'nctId': 'NCT01869660', 'briefTitle': 'Shared Decision Making for Patients With First-admission Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University'}, 'officialTitle': 'Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SDMS-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shared Decision Making', 'description': 'The present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments.', 'interventionNames': ['Behavioral: Shared Decision Making']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients with no special program about decision making.'}], 'interventions': [{'name': 'Shared Decision Making', 'type': 'BEHAVIORAL', 'description': 'The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.', 'armGroupLabels': ['Shared Decision Making']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Numazu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Numazu Chuou Hospital', 'geoPoint': {'lat': 35.1, 'lon': 138.86667}}], 'overallOfficials': [{'name': 'Yoshio Hirayasu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychiatry, Yokohama City University School of Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}