UMIN-CTR Clinical Trial

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
Email	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
Email	honda-1@umin.ac.jp

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054057