UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009239
Receipt No. R000010849
Scientific Title Comparison of Shared Decision Making (SDM) and Routine Care for University Students in Psychiatric Outpatient Clinic. A Randomized Controlled Trial.
Date of disclosure of the study information 2012/11/01
Last modified on 2017/07/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of Shared Decision Making (SDM) and Routine Care for University Students in Psychiatric Outpatient Clinic. A Randomized Controlled Trial.
Acronym Comparison of SDM and Routine Care in Psychiatric Clinic.
Scientific Title Comparison of Shared Decision Making (SDM) and Routine Care for University Students in Psychiatric Outpatient Clinic. A Randomized Controlled Trial.
Scientific Title:Acronym Comparison of SDM and Routine Care in Psychiatric Clinic.
Region
Japan

Condition
Condition Schizophrenia, Mood Disorders, Neurotic Disorders, Attention Deficit Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To examine the patient-oriented decision-making process in psychiatric treatment and the role of primary health nurse, evaluating patient satisfaction with routine care and SDM.
2) To determine whether SDM intervention would improve patient satisfaction, medication adherence, and depression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) patient satisfaction with routine care and SDM.

2) patient satisfaction, clinic visits, medication adherence, and depression every 2 weeks until 24 weeks after decision making.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 routine care
Interventions/Control_2 Shared Decision Making intervention
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria First visit to psychiatric clinic at Waseda University Health Support Center.
Key exclusion criteria 1)severe and suicidal ideation
2)refusal of SDM
3)difficulty understanding things
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name AOKI, Yumi
Organization Waseda University
Division name Health Support Center
Zip code
Address 1-104 Totsuka, Shinjuku, Tokyo
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Waseda University
Division name Health Support Ceter
Zip code
Address 1-104 Totsuka, Shinjuku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Health Supprot Center, Waseda University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 01 Day
Last modified on
2017 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010849

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.