UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049634 |
|---|---|
| Receipt number | R000056522 |
| Scientific Title | Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2025/06/09 15:24:41 |
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Basic information
Public title
Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study
Acronym
Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study
Scientific Title
Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study
Scientific Title:Acronym
Post Intensive Care Syndrome assessment instruments: a scoping review and Delphi method study
Region
| Japan |
Condition
Condition
Post Intensive Care Syndrome
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find the appropriate method to evaluate PICS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appropriate evaluation method about physical, mental, cognitive, QOL, ADL after the hospital discharge
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
The assessment instruments about physical function, cognitive function, mental health, quality of life, ADL adult ICU survivors or their family assessed after hospital discharge
Key exclusion criteria
reviw, protocol, trial resisgry, case report, conference abstract, and study based on other language than English
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Graduate School of Medicine, Kobe University
Division name
Department of Disaster and Emergency Medicine
Zip code
6500017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe
TEL
078-382-6521
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Graduate School of Medicine, Kobe University
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe
TEL
078-382-6521
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Kobe university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2022 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://ccforum.biomedcentral.com/articles/10.1186/s13054-023-04681-6
Publication of results
Published
Result
URL related to results and publications
https://ccforum.biomedcentral.com/articles/10.1186/s13054-023-04681-6
Number of participants that the trial has enrolled
6972
Results
The modified Delphi meeting reached 20 PICS assessment instrument recommendations: (1) in the physical domain: the 6-min walk test, MRC score, and grip strength, (2) in cognition: MoCA, MMSE, and SMQ, (3) in mental health: HADS, IES-R, and PHQ-9, (4) in the activities of daily living: the Barthel Index, IADL, and FIM, (5) in quality of life: SF-36, SF-12, EQ-5D-5L, 3L, and VAS (6), in sleep and pain: PSQI and Brief Pain Inventory, respectively, and (7) in the PICS-family domain: SF-36, HADS, and IES-R.
Results date posted
| 2025 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 6972 records were identified in this scoping review, and 754 studies were included in the analysis. After data extraction, 107 PICS assessment instruments were identified.
Participant flow
Scoping review
Adverse events
None
Outcome measures
PICS assessment method
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No ethical committee due to the scoping review and delphi method
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056522
