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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042158
Receipt No. R000048121
Scientific Title An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Date of disclosure of the study information 2020/10/19
Last modified on 2020/10/19

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Basic information
Public title An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Acronym An observational study for epidemiology and treatment strategy for PICS
Scientific Title An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Scientific Title:Acronym An observational study for epidemiology and treatment strategy for PICS
Region
Japan

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

Objectives
Narrative objectives1 This study aims at describing the prevalence of post-ICU syndrome (PICS) in patients treated under limited family contact, using patient information and questionnaires. The study will continue after family visits are freed, and will observer the difference between the two phases. the study will also attempt to identify possible prevention strategy for PICS.
Basic objectives2 Others
Basic objectives -Others study of epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of limited family visits on the prevalence of PICS
Key secondary outcomes The overall prevalence of PICS in ICU patients
The effect of severity and treatment on the occurrence of PICS
The effect of family involvement on PICS

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 1. Age 20 years and older
2. ICU treatment more than 3 days
Key exclusion criteria 1. age under 20 years
2. less than 3 days in ICU
3. patients after elective surgery
4. others decided by investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Taka-aki
Middle name
Last name Nakada
Organization Chiba University Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL 043-226-2341
Email chibadaieccm-office@umin.ac.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Oshima
Organization Chiba University Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL 043-226-2341
Homepage URL
Email t_oshima@chiba-u.jp

Sponsor
Institute Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
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 Institutional Review Board, Chiba University Graduate School of Medicine
Address 1-8-1 Inohana Chuo-ku, Chiba City, Chiba
Tel 043-222-7171
Email inohana-rinri@chiba-u.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 10 Month 19 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 05 Month 28 Day
Date of IRB
2020 Year 05 Month 28 Day
Anticipated trial start date
2020 Year 10 Month 12 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 10 Month 19 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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