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Shared Decision Making for Patients With First-admission Schizophrenia

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ClinicalTrials.gov Identifier: NCT01869660
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Yokohama City University

Brief Summary:
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Shared Decision Making Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Shared Decision Making
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.
Behavioral: Shared Decision Making
The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.

No Intervention: Usual Care
Patients with no special program about decision making.



Primary Outcome Measures :
  1. Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Within 7days before the date of discharge ]

Secondary Outcome Measures :
  1. Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10) [ Time Frame: Within 7days before the date of discharge ]
  2. Treatment continuation as measured by the rate of outpatient attendance during the 30 days [ Time Frame: 6 months after discharge ]


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to an acute care psychiatric ward.
  • Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
  • Aged 16 to 65 years old at admission
  • No prior experience of psychiatric admission (first-admission)

Exclusion Criteria:

  • Diagnosed with moderate to severe mental retardation
  • Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
  • Having poor Japanese language skill
  • Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869660


Locations
Japan
Numazu Chuou Hospital
Numazu, Shizuoka, Japan
Sponsors and Collaborators
Yokohama City University
Investigators
Study Chair: Yoshio Hirayasu, PhD Department of Psychiatry, Yokohama City University School of Medical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yokohama City University
ClinicalTrials.gov Identifier: NCT01869660     History of Changes
Other Study ID Numbers: SDMS-S
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: August 2015

Keywords provided by Yokohama City University:
First hospitalization

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders