UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048250 |
|---|---|
| Receipt number | R000054993 |
| Scientific Title | Study of delirium preventive effect and delirium preventive factor by Derilium Team Approach Program |
| Date of disclosure of the study information | 2022/07/03 |
| Last modified on | 2024/07/03 18:01:34 |
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Basic information
Public title
Study of delirium preventive effect and delirium preventive factor by Derilium Team Approach Program
Acronym
Study of delirium by DELTA program
Scientific Title
Study of delirium preventive effect and delirium preventive factor by Derilium Team Approach Program
Scientific Title:Acronym
Study of delirium by DELTA program
Region
| Japan |
Condition
Condition
derilium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of delirium-preventing effects and delirium-preventing factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized within the period
Key exclusion criteria
Other than the above age
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nitta |
Organization
Kanazawa Medical University
Division name
Psychiatry and Neuroscience
Zip code
920-0293
Address
1-1, Daigaku, Uchinada, Ishikawa
TEL
0762862211
nta-ysk@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nitta |
Organization
Kanazawa Medical University
Division name
Psychiatry and Neuroscience
Zip code
920-0293
Address
1-1, Daigaku, Uchinada, Ishikawa
TEL
0762862211
Homepage URL
nta-ysk@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical 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
Kanazawa Medical University
Address
1-1, Daigaku, Uchinada, Ishikawa
Tel
0762862211
nta-ysk@kanazawa-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
84
Results
Attention should be paid to abnormal electrolytes and constipation as preventive measures for postoperative delirium in the orthopedic ward. Minimizing room transfers as an environmental factor may help prevent delirium.
Results date posted
| 2024 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to evaluate the preventive effect of delirium and identify delirium predictors in the wards where the DELTA program has been introduced.
Management information
Registered date
| 2022 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054993
