UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014697 |
|---|---|
| Receipt number | 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 11:11:43 |
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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
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
| 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
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
sosei.yama@ncnp.go.jp
Sponsor or person
Institute
Department of Psychiatric Rehabilitation, National Institute of Mental Health,
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017084
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
