UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023743
Receipt No. R000027346
Scientific Title Long term physical function and mental health among intensive care unit survivors: a 1-year longitudinal study
Date of disclosure of the study information 2016/09/01
Last modified on 2018/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Long term physical function and mental health among intensive care unit survivors: a 1-year longitudinal study
Acronym Physical function and mental health among intensive care unit survivors
Scientific Title Long term physical function and mental health among intensive care unit survivors: a 1-year longitudinal study
Scientific Title:Acronym Physical function and mental health among intensive care unit survivors
Region
Japan

Condition
Condition Patients who admit to the intensive care unit
Classification by specialty
Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the epidemiological data of post intensive care syndrome (PICS) in Japan. To investigate the physical function and mental health of intensive care unit (ICU) survivors at 3 and 12 month after discharge.
Basic objectives2 Others
Basic objectives -Others Description of epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Modified Barthel Index (mBI), Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale-Revised (IES-R) at 3 and 12 months after ICU discharge
Key secondary outcomes Survival rate, living place and memory of ICU stay at 3 and 12 months after ICU discharge

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are admitted to the ICU
Key exclusion criteria Extremely severe cases who are expected to die within 48 hours
Cases with limitations in life support
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kyohei Miyamoto
Organization Wakayama Medical Universty
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, JAPAN
TEL 073-441-0603
Email wakayama.pics@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Kyohei Miyamoto
Organization Wakayama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, JAPAN
TEL 073-441-0603
Homepage URL
Email wakayama.pics@gmail.com

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
2020 Year 01 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information Nothing special

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.