UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological study of post-intensive care syndrome in critically ill patients admitted to intensive care units and their families.
Acronym	Epidemiological study of post-intensive care syndrome in critically ill patients admitted to intensive care units and their families.
Scientific Title	Epidemiological study of post-intensive care syndrome in critically ill patients admitted to intensive care units and their families.
Scientific Title:Acronym	JPICS Database
Region	Japan

Condition
Condition	Patients 16 years of age or older admitted to the intensive care unit and their family members.
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It has been reported that the onset of postintensive care syndrome (PICS) has a significant impact on patients and their families, as well as a significant burden on the medical economy. However, no large-scale epidemiological survey has been conducted in Japan, and there is a need to establish basic data to promote PICS research. The purpose of this study is to clarify the long-term prognosis and quality of life of critically ill patients admitted to intensive care units in Japan, and to determine the presence or absence of mental disorders in the families of critically ill patients. The database to be constructed in this study is the Japanese version of the PICS database (JPICS), which will be conducted as a committee activity of the Japanese Intensive Care Medicine PICS Measures and Quality of Life Improvement Study Committee.
Basic objectives2	Others
Basic objectives -Others	epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Short-Memory Questionnaire (SMQ), Barthel Index, Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale-Revised (IES-R), EuroQol 5 Dimension (EQ-5D)-5L, EQ-5D-VAS and other visual analogue scales Primary endpoint (family): Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale-Revised (IES-R), Pittsburg Sleep Quality Index (PSQI), EQ-5D-VAS, etc. visual analogue scale
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients 16 years of age or older admitted to the intensive care unit and their family members
Key exclusion criteria	Patients and their families who have indicated that they do not wish to participate in the study
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name HATAKEYAMA
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka
TEL	072-683-1221
Email	junji.hatakeyama@ompu.ac.jp

Public contact
Name of contact person	1st name Junji Middle name Last name HATAKEYAMA
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka
TEL	072-683-1221
Homepage URL
Email	junji.hatakeyama@ompu.ac.jp

Sponsor
Institute	Japanese Society of Intensive Care Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Medical and Pharmaceutical University
Address	2-7 Daigaku-machi, Takatsuki, Osaka
Tel	072-683-1221
Email	rinri@ompu.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	2023 Year 01 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	Enrolling by invitation
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB	2022 Year 09 Month 02 Day
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2026 Year 12 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	2022 Year 12 Month 04 Day
Last modified on	2022 Year 12 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056590