UMIN-CTR Clinical Trial

Basic information
Public title	Implementation of delirium care after an operation in a gastrointestinal surgery ward
Acronym	Implementation of delirium care after an operation in a gastrointestinal surgery ward
Scientific Title	Implementation of delirium care after an operation in a gastrointestinal surgery ward
Scientific Title:Acronym	Implementation of delirium care after an operation in a gastrointestinal surgery ward
Region	Japan

Condition
Condition	Delirium
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A nurse acquires knowledge of delirium as a result of the education to a nurse, and a period of the number of patients who develop delirium at the same time and delirium diminishes in whether I was able to care now, and it was possible to stop fall falls by delirium or I make it clear.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mentioning for a questionnaire survey is unnecessary.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	1) Nurse manager and a nursing study member take a delirium care course and learn use method for delirium assessment seat introduction. 2) I question about the degree of the knowledge and the implementation situation of the care of the delirium care before a delirium care study meeting and investigate about the degree of the knowledge and correspondence to delirium of our ward nurse. 3) a study meeting is performed about delirium care and use method of an assessment seat targeted for the nurse. 4) the degree of the knowledge and the implementation situation of the care of the delirium care are measured using just after the study meeting end and the same one as a questionnaire which was performed before a study meeting 6 months later. 5) a questionnaire result is analyzed using rank sum test with a sign of Wilcoxon.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient hospitalized at the general anesthesia destinations of a gullet and a liver by gastrointestinal surgery
Key exclusion criteria	Local anesthesia is removed
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Chie Middle name Last name Harada
Organization	Kochi Medical School Hospital
Division name	Nursing Department
Zip code	783-8505
Address	Okochokohasu, Nankoku-shi, Kochi.
TEL	088-880-2459
Email	jm-c-harada@kochi-u.ac.jp

Public contact
Name of contact person	1st name Harada Middle name Last name Chie
Organization	Kochi Medical School Hospital
Division name	Nursing Department
Zip code	7883-8505
Address	Okochokohasu, Nankoku-shi, Kochi.
TEL	088-880-2459
Homepage URL
Email	jm-c-harada@kochi-u.ac.jp

Sponsor
Institute	Kochi Unversity
Institute
Department

Funding Source
Organization	Kochi Unversity
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	Kochi Medical School Hospital
Address	Okochokohasu, Nankoku-shi, Kochi.
Tel	088-880-2459
Email	jm-c-harada@kochi-u.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	高知大学医学部附属病院（高知県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 08 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	2018 Year 06 Month 30 Day
Date of IRB	2018 Year 04 Month 26 Day
Anticipated trial start date	2018 Year 06 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 08 Day
Last modified on	2021 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037540