UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054665 |
|---|---|
| Receipt number | R000061724 |
| Scientific Title | Satisfaction survey on a tool to optimize treatment of depression by integrating medical information: a prospective cohort study |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/12/13 09:27:35 |
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Basic information
Public title
Satisfaction survey on a tool to optimize treatment of depression by integrating medical information: a prospective cohort study
Acronym
Satisfaction Survey on Treatment Optimization Tools for Depression Integrating Medical Information
Scientific Title
Satisfaction survey on a tool to optimize treatment of depression by integrating medical information: a prospective cohort study
Scientific Title:Acronym
Satisfaction survey on a tool to optimize treatment of depression by integrating medical information: a prospective cohort study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey on patient satisfaction and trust between patients and physicians in clinical settings for the alpha version of Optima-D, a depression treatment optimization tool that combines functions to predict remission and support ongoing treatment.
Basic objectives2
Others
Basic objectives -Others
Gather basic information for conducting a usefulness validation study of Optima-D, a tool for optimizing depression treatment
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with the practice using the tool: Client Satisfaction Questionnaire-8J (CSQ-8J)
Key secondary outcomes
Satisfaction with treatment: Clinical Satisfaction Questionnaire-8J (CSQ-8J)
Trust in physicians: Japanese version of the Trust in Physician Scale (TPS)
Depressive symptoms: GRID-Hamilton Depression Rating Scale (HAMD-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI-II)
QOL: The World Health Organization-Quality of Life Assessment (WHOQOL26)
Tool issues, frequency of tool use (number of accesses to the tool, access time, access page)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who meet the diagnostic criteria for depression in DSM-5
(2) Those who are at least 18 years old at the time of consent acquisition
(3) Those who understand the purpose and content of this study and have obtained written consent from the individual to participate in the study of their own free will
Key exclusion criteria
(1) Those with a history of severe organic brain lesions or cognitive dysfunction
(2) Those with a clinically diagnosed life-threatening or unstable physical condition at the time of screening
(3) Others deemed by the principal investigator to be ineligible for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Keio University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
t-kick.z3@keio.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
t-kick.z3@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medicine Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 14 | 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
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Satisfaction Survey on Treatment Optimization Tool for Depression with Integrated Medical Information
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061724
