UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047399 |
|---|---|
| Receipt number | R000054057 |
| Scientific Title | Association between delirium and multimodal care communication education in a stroke care unit. |
| Date of disclosure of the study information | 2022/04/05 |
| Last modified on | 2022/04/05 16:51:58 |
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Basic information
Public title
Association between delirium and multimodal care communication education in a stroke care unit.
Acronym
Association between delirium and multimodal care communication education in a stroke care unit.
Scientific Title
Association between delirium and multimodal care communication education in a stroke care unit.
Scientific Title:Acronym
Association between delirium and multimodal care communication education in a stroke care unit.
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effectiveness of multimodal care communication education for nurses in stroke patients in a stroke care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium in stroke patients in stroke care units.
Key secondary outcomes
Length of stay, 30-day readmission rate and 1-year survival rate of stroke patients admitted to stroke care units.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients who were age over 20 and were admitted to stroke care unit.
Key exclusion criteria
.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Miwako |
| Middle name | |
| Last name | Honda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Geriatric Research Division
Zip code
1520021
Address
2-5-1 Higashigaoka, Meguro, Tokyo, Japan
TEL
0334110111
honda-1@umin.ac.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Honda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Geriatric Research Division
Zip code
1520021
Address
2-5-1 Higashigaoka, Meguro, Tokyo, Japan
TEL
0334110111
Homepage URL
honda-1@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center
Address
Meguro
Tel
0334110111
miwako.honda@tmcgrc.org
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
聖マリア病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
St Mary's Hospital, Kurume, Fukuoka, introduced staff education on multimodal care communication techniques for nursing staff in the stroke care unit in 2016. This is an observational study on the incidence of delirium in hospitalised patients before and after the introduction of this staff education in patients admitted to the Stroke Care Unit of the hospital between 1 September 2014 and 31 August 2018.
Management information
Registered date
| 2022 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054057
| Research Plan | |
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| 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 |
