UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042310
Receipt No. 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

* 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 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
Email 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
Email mami517@wakayama-med.ac.jp

Sponsor
Institute Wakayama Mediccal 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 Wakayama Medical University
Address 811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
Tel 073-447-2300
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048303

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.