UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042310 |
|---|---|
| Receipt number | R000048303 |
| Scientific Title | ICU diary for reduction of Post-Intensive Care Syndrome among critical ill patients: prospective observational study compared with historical cohort data. |
| Date of disclosure of the study information | 2020/11/09 |
| Last modified on | 2020/11/01 11:07:16 |
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Basic information
Public title
ICU diary for reduction of Post-Intensive Care Syndrome among critical ill patients: prospective observational study compared with historical cohort data.
Acronym
The effect of ICU diary for reduction of Post-Intensive Care Syndrome among critical ill patients
Scientific Title
ICU diary for reduction of Post-Intensive Care Syndrome among critical ill patients: prospective observational study compared with historical cohort data.
Scientific Title:Acronym
The effect of ICU diary for reduction of Post-Intensive Care Syndrome among critical ill patients
Region
| Japan |
Condition
Condition
Patients who admit to the intensive care syndrome
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect for mental health of post-intensive care syndrome (PICS) by intensive care unit (ICU) diary among ICU survivors at 3 month after discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Impact of Event Scale-Revised (IES-R) to evaluate post-traumatic stress disorder (PTSD) at 3 month after ICU discharge
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all the following.
Patients who are emergently admitted to the ICU.
Patients aged 20 years or older
Patients who are expected to stay in ICU for 48 hours at least.
Patients with family or caregivers.
Key exclusion criteria
Patinets who meet any of the following.
Patients who are expected to die within 48hr.
Patients with limitation in life support.
Patients with diseases that directly influence brain injury.
Patients with dementia or mental disease that is diagnosed.
Patients without family or caregiver.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medial University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
TEL
073-441-0603
gomadofu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Shibata |
Organization
Wakayama Medial University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
TEL
073-441-0603
Homepage URL
mami517@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Mediccal 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
| 2020 | Year | 11 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special
Management information
Registered date
| 2020 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048303
