UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046069 |
|---|---|
| Receipt number | R000052579 |
| Scientific Title | Description of post-intensive care syndrome-family in critically ill patients: single center longitudinal study |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2021/11/15 01:54:01 |
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Basic information
Public title
Description of post-intensive care syndrome-family in critically ill patients: single center longitudinal study
Acronym
W-PICS-F
Scientific Title
Description of post-intensive care syndrome-family in critically ill patients: single center longitudinal study
Scientific Title:Acronym
W-PICS-F
Region
| Japan |
Condition
Condition
Families of patients admitting intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe epidemiology of post-intensive care syndrome-family in Japan
Basic objectives2
Others
Basic objectives -Others
To describe epidemiology of post-intensive care syndrome-family in Japan
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychiatric symptoms such as anxiety, depression, and PTSD symptoms at 3 and 12 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Families of patients staying intensive care units for 4 or more days.
Key exclusion criteria
Families with psychiatric illness
Families aged less than 18 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
TEL
+81-73-447-2300
gomadofu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
TEL
+81-73-447-2300
Homepage URL
gomadofu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Department of Emergency and Critical Care 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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
Tel
+81-73-447-2300
gomadofu@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
和歌山県立医科大学救急集中治療医学講座
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | 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
Descriptive study for PICS-F
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052579
