UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Title of the study (Brief title)	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	Sachiko Inoue
Organization	Uwajima City Hospital
Division name	Department of Nursing
Address	1-1,Goten-machi,Uwajima
TEL	0895-25-1111
Email	s.inoue@uwajima-mh.jp

Public contact
Name of contact person	Sachiko Inoue
Organization	Uwajima City Hospital
Division name	Department of Nursing
Address	1-1,Goten-machi,Uwajima
TEL	0895-25-1111
Homepage URL
Email	s.inoue@uwajima-mh.jp

Sponsor
Institute	Uwajima City Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028864