UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effects of a personal computer tool for facilitating shared decision making: a pilot study
Title of the study (Brief title)	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

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

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	Junichiro Ito
Organization	National Center of Neurology and Psychiatry
Division name	Department of Psychiatric Rehabilitation, National Institute of Mental Health
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL	042-346-2168
Email	junito@ncnp.go.jp

Public contact
Name of contact person	Sosei Yamaguchi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Psychiatric Rehabilitation, National Institute of Mental Health
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017084