UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018775
Receipt number R000021721
Scientific Title Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.
Date of disclosure of the study information 2015/08/23
Last modified on 2018/10/11 22:51:24

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Basic information

Public title

Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.

Acronym

Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.

Scientific Title

Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.

Scientific Title:Acronym

Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.

Region

Japan


Condition

Condition

Patients in intensive care units (ICUs)

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determine baseline urinary catheter point prevalence in multipie hospital in Japan

Basic objectives2

Others

Basic objectives -Others

Implement a multimodal intervention to reduce the unnecessary use of indwelling urinary catheters and assess the efficacy of the intervention

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Prevalence of the appropriate use of urinary catheters

Key secondary outcomes

Prevalence of the use of urinary catheters


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A multimodal approach to reduce the unnecessary use of urinary catheters including education to nurses for 2 months and then the prevalence of urinary catheter will be measured (Pre-intervention phase)

Interventions/Control_2

Usual care (Post-intervention phase)

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All adults patients who are admitted to ICUs

Key exclusion criteria

Nothing spectacular

Target sample size

438


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Kuriyama

Organization

Kurashiki Central Hospital

Division name

Department of General Medicine

Zip code


Address

1-1-1 Miwa Kurashiki Okayama 710-8602 JAPAN

TEL

086-422-0210

Email

akira-kuriyama-jpn@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Kuriyama

Organization

Kurashiki Central Hospital

Division name

Department of General Medicine

Zip code


Address

1-1-1 Miwa Kurashiki Okayama 710-8602 JAPAN

TEL

086-422-0210

Homepage URL


Email

akira-kuriyama-jpn@yahoo.co.jp


Sponsor or person

Institute

Kurashiki Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Kurashiki Central Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

水戸協同病院(茨城県)
神戸中央市民病院(兵庫県)
浦添総合病院(沖縄県)
JA広島総合病院(広島県)
倉敷中央病院(岡山県)
University of Michigan(米国)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 23 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

No longer recruiting

Date of protocol fixation

2015 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 24 Day

Last follow-up date

2017 Year 06 Month 20 Day

Date of closure to data entry

2017 Year 06 Month 30 Day

Date trial data considered complete

2017 Year 07 Month 01 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 23 Day

Last modified on

2018 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021721


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name