UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058978 |
|---|---|
| Receipt number | R000067449 |
| Scientific Title | Establishment of a Comprehensive Outpatient Support System to Improve Long-Term Prognosis of Critically Ill Patients and Elucidation of Risk Factors that Decrease Quality of Life |
| Date of disclosure of the study information | 2025/09/03 |
| Last modified on | 2025/09/03 12:25:16 |
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Basic information
Public title
Follow-up outpatient clinic after ICU discharge: a single-center prospective observational study
Acronym
PICS clinic: A single-center prospective observational study
Scientific Title
Establishment of a Comprehensive Outpatient Support System to Improve Long-Term Prognosis of Critically Ill Patients and Elucidation of Risk Factors that Decrease Quality of Life
Scientific Title:Acronym
Comprehensive outpatient support system to improve long-term prognosis of critically ill patients
Region
| Japan |
Condition
Condition
Critically ill patient admitted to ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a follow-up outpatient system for critically ill patients and their families, to clarify the long-term prognosis, functional impairment, and quality of life of critically ill patients admitted to intensive care units, and to clarify the presence of mental disorders in the families of critically ill patients. In addition, we aim to elucidate the risk factors that may reduce the functional impairment and quality of life of these patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients: SF-36v2 Japanese version, EQ-5D-VAS, Pittsburgh Sleep Questionnaire, Japanese version of MoCA (MoCa-J), and painDETECT Japanese version at 1 month and 3 months after ICU discharge
Family: HADS, IES-R, Pittsburgh Sleep Questionnaire, EQ-5D-5L, EQ-5D-VAS at 1 month and 3 months 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the Osaka Medical and Pharmaceutical University Hospital Emergency Center and their family members
Key exclusion criteria
Research subjects whom the principal investigator or physician in charge deems inappropriate for the safe conduct of this research
Target sample size
180
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
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
junji.hatakeyama@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Medical and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki, Osaka
Tel
072-683-1221
junji.hatakeyama@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
| 2025 | Year | 09 | Month | 03 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067449
