UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025101 |
|---|---|
| Receipt number | R000028864 |
| Scientific Title | Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2018/06/07 16:42:22 |
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Basic information
Public title
Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Acronym
Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Scientific Title
Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Scientific Title:Acronym
Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of early intervention for patients with delirium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the number of accidental catheter removal associated with occurrence of delirium
Key secondary outcomes
age, gender,
Day and time when accidental catheter removal happened,
Changes of the condition before and after accidental catheter removal, PS,
Drugs used for sleepless or restless Consultation to psychiatrist
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
To build up the unified system of early intervention for patients with delirium
Interventions/Control_2
Usual care
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.admitted patients in emergency 2.patients who needed intravenous drip infusion
3. Patients who obtained informed consent for research
Key exclusion criteria
Patients who could obtain informed for research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiko Inoue |
Organization
Uwajima City Hospital
Division name
Department of Nursing
Zip code
Address
1-1,Goten-machi,Uwajima
TEL
0895-25-1111
s.inoue@uwajima-mh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Inoue |
Organization
Uwajima City Hospital
Division name
Department of Nursing
Zip code
Address
1-1,Goten-machi,Uwajima
TEL
0895-25-1111
Homepage URL
s.inoue@uwajima-mh.jp
Sponsor or person
Institute
Uwajima City Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028864
