Shared Decision Making for Patients With First-admission Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Shared Decision Making
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring First hospitalization
Eligibility 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.
Sites / Locations
- Numazu Chuou Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Shared Decision Making
Usual Care
Arm 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.
Patients with no special program about decision making.
Outcomes
Primary Outcome Measures
Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)
Secondary Outcome Measures
Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)
Treatment continuation as measured by the rate of outpatient attendance during the 30 days
Full Information
NCT ID
NCT01869660
First Posted
May 27, 2013
Last Updated
December 29, 2015
Sponsor
Yokohama City University
1. Study Identification
Unique Protocol Identification Number
NCT01869660
Brief Title
Shared Decision Making for Patients With First-admission Schizophrenia
Official Title
Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yokohama City University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
First hospitalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shared Decision Making
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients with no special program about decision making.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making
Intervention Description
The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Treatment continuation as measured by the rate of outpatient attendance during the 30 days
Time Frame
6 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshio Hirayasu, PhD
Organizational Affiliation
Department of Psychiatry, Yokohama City University School of Medical
Official's Role
Study Chair
Facility Information:
Facility Name
Numazu Chuou Hospital
City
Numazu
State/Province
Shizuoka
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28166757
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.
Results Reference
derived
PubMed Identifier
24725910
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.
Results Reference
derived
Learn more about this trial
Shared Decision Making for Patients With First-admission Schizophrenia
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