UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Acronym	Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Scientific Title	AAEM multicentre retrospective study
Scientific Title:Acronym	AAEM multicentre retrospective study
Region	Japan

Condition
Condition	ICU patients
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the relationship between PICS and patient outcomes using the Euro QOL 5 Dimension (EQ-5D-5L) as a surrogate outcome by investigating the actual release (frequency and intensity) in a multi-centre setting where standard rehabilitation is provided.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Euro-QOL at discharge from hospital (EQ-5D-5L)
Key secondary outcomes

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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients admitted to the ICU in a certain 2-month period
Key exclusion criteria	(1) Under 18 years old 2) Patients who are expected to be discharged from ICU within 48 hours (e.g., follow-up after scheduled surgery, dialysis only) 3) Diseases presenting central nervous system disorder (stroke, severe head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary resuscitation with hypoxic encephalopathy, cervical cord injury with consciousness disorder, cerebrovascular dementia, Alzheimer's disease, Parkinson's disease, etc.) (4) Patients who have difficulty in communicating in Japanese and cooperating in rehabilitation, such as foreigners (including schizophrenia, anxiety neurosis, depression, autism, etc.) (5) Patients who were unable to walk even with the use of assistive devices before admission (using services requiring nursing care 3 or more: standard) 6) End of life/Terminal care cases where treatment is not the aim
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Fujizuka
Organization	Japan Red Cross Maebashi Hospital
Division name	Advanced Medical Emergency Department and Critical Care Center
Zip code	371-0811
Address	389-1 Asakura-cho, Maebashi-shi, Gunma
TEL	+81272653333
Email	fujiken_sanjo_4138@yahoo.co.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Fujizuka
Organization	Japan Red Cross Maebashi Hospital
Division name	Advanced Medical Emergency Department and Critical Care Center
Zip code	371-0811
Address	389-1 Asakura-cho, Maebashi-shi, Gunma
TEL	+81272653333
Homepage URL
Email	fujiken_sanjo_4138@yahoo.co.jp

Sponsor
Institute	Japan Red Cross Maebashi Hospital Advanced Medical Emergency Department and Critical Care Center
Institute
Department

Funding Source
Organization	NA
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	Japan Red Cross Maebashi Hospital
Address	389-1 Asakura-cho, Maebashi-shi, Gunma
Tel	+81 27-265-3333
Email	fujiken_sanjo_4138@yahoo.co.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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 01 Day

Related information
URL releasing protocol	not available
Publication of results	Unpublished

Result
URL related to results and publications	not available
Number of participants that the trial has enrolled	200
Results	Under analysis
Results date posted	2021 Year 10 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Under analysis
Participant flow	Under analysis
Adverse events	Under analysis
Outcome measures	Under analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 06 Month 15 Day
Date of IRB	2019 Year 07 Month 05 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing particular at this moment

Management information
Registered date	2021 Year 10 Month 01 Day
Last modified on	2021 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052088