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Recruitment status Completed
Unique ID issued by UMIN UMIN000014697
Receipt No. R000017084
Scientific Title Evaluation of effects of a personal computer tool for facilitating shared decision making: a pilot study
Date of disclosure of the study information 2014/07/30
Last modified on 2017/04/01

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Basic information
Public title Evaluation of effects of a personal computer tool for facilitating shared decision making: a pilot study
Acronym Evaluation of a SDM tool: pilot study
Scientific Title Evaluation of effects of a personal computer tool for facilitating shared decision making: a pilot study
Scientific Title:Acronym Evaluation of a SDM tool: pilot study
Region
Japan

Condition
Condition Psychiatric disorders, excluding substance abuse, dementia and neurosis
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of a PC tool (personal computer software) for facilitating shared decision making on patient-doctor relationship and psychiatric symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient-doctor relationship, trust on doctor, patient's activation, level of shared decision making
Key secondary outcomes QOL, service satisfaction, degree of recovery, psychiatric symptoms, adverse effect, functioning, weight, adherence

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 In the intervention group, patients use the SDM tool (PC software) with a peer-staff, and input information relevant to their own hope and conditions to the SDM tool before their every clinical examination. The patient and his/her psychiatrist share their decision making for his/her treatment based on the information inputted in the SDM tool. This information is also shared with his/her case manager. The period of the intervention will be two months for preparation to use the SDM tool and six months for using the SDM tool and for shared decision making with his/her psychiatrist. It would take 30 minutes for per use of SDM tools.
Interventions/Control_2 In the control group, usual clinical examination will be continued for eight months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who use psychiatric day care or home-visit nursing (outreach services) in the study sites
Key exclusion criteria Main diagnosis is substance abuse, dementia or neurosis
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichiro Ito
Organization National Center of Neurology and Psychiatry
Division name Department of Psychiatric Rehabilitation, National Institute of Mental Health
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL 042-346-2168
Email junito@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sosei Yamaguchi
Organization National Center of Neurology and Psychiatry
Division name Department of Psychiatric Rehabilitation, National Institute of Mental Health
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL 042-346-2168
Homepage URL
Email sosei.yama@ncnp.go.jp

Sponsor
Institute Department of Psychiatric Rehabilitation, National Institute of Mental Health,
National Center of Neurology and Psychiatry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Grant-in-Aid for Scientific Research (B)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 国立精神・神経医療研究センター病院(東京都)、国分寺すずかけ心療クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 30 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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 29 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 09 Month 01 Day
Date trial data considered complete
2016 Year 10 Month 01 Day
Date analysis concluded
2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 29 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017084


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