UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009239 |
|---|---|
| Receipt number | 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 13:36:29 |
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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
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
Public contact
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
Sponsor or person
Institute
Health Supprot Center, Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010849
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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