UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023743 |
|---|---|
| Receipt number | 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 | 2020/09/02 13:42:07 |
* 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
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical Universty
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, JAPAN
TEL
073-441-0603
wakayama.pics@gmail.com
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, JAPAN
TEL
073-441-0603
Homepage URL
wakayama.pics@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, JAPAN
Tel
073-447-2300
wa-rinri@wakayama-med.ac.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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/ams2.557
Number of participants that the trial has enrolled
204
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
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
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027346
