UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049634
Receipt number R000056522
Scientific Title Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study
Date of disclosure of the study information 2022/11/28
Last modified on 2022/11/28 16:55:32

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Basic information

Public title

Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study

Acronym

Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study

Scientific Title

Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study

Scientific Title:Acronym

Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study

Region

Japan


Condition

Condition

Post Intensive Care Syndrome

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find the appropriate method to evaluate PICS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Appropriate evaluation method about physical, mental, cognitive, QOL, ADL after the hospital discharge

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The assessment instruments about physical function, cognitive function, mental health, quality of life, ADL adult ICU survivors or their family assessed after hospital discharge

Key exclusion criteria

reviw, protocol, trial resisgry, case report, conference abstract, and study based on other language than English

Target sample size



Research contact person

Name of lead principal investigator

1st name Nobuto
Middle name
Last name Nakanishi

Organization

Graduate School of Medicine, Kobe University

Division name

Department of Disaster and Emergency Medicine

Zip code

6500017

Address

7-5-2 Kusunoki, Chuo-ward, Kobe

TEL

078-382-6521

Email

nobuto_nakanishi@yahoo.co.jp


Public contact

Name of contact person

1st name Nobuto
Middle name
Last name Nakanishi

Organization

Graduate School of Medicine, Kobe University

Division name

Department of Disaster and Emergency Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki, Chuo-ward, Kobe

TEL

078-382-6521

Homepage URL


Email

nobuto_nakanishi@yahoo.co.jp


Sponsor or person

Institute

Kobe university

Institute

Department

Personal name



Funding Source

Organization

Kobe university

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

NA

Address

NA

Tel

NA

Email

NA


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

2022 Year 11 Month 28 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

2022 Year 11 Month 27 Day

Date of IRB

2022 Year 11 Month 27 Day

Anticipated trial start date

2022 Year 11 Month 28 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No ethical committee due to the scoping review and delphi method


Management information

Registered date

2022 Year 11 Month 28 Day

Last modified on

2022 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056522