UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061270 |
|---|---|
| Receipt number | R000070107 |
| Scientific Title | Establishment of a Comprehensive Outpatient Support System to Improve Long-Term Outcomes for Severely Ill Patients and Identification of Risk Factors That Impair Quality of Life |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/15 14:04:33 |
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Basic information
Public title
Follow-up outpatient visits for critically ill patients after discharge from the ICU
Acronym
Follow-up outpatient visits for critically ill patients
Scientific Title
Establishment of a Comprehensive Outpatient Support System to Improve Long-Term Outcomes for Severely Ill Patients and Identification of Risk Factors That Impair Quality of Life
Scientific Title:Acronym
Establishment of a Comprehensive Outpatient Support System for Severely Ill Patients
Region
| Japan |
Condition
Condition
Critically ill patients admitted to the ICU
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to establish an outpatient follow-up system for critically ill patients and their families, with the aim of clarifying the long-term prognosis, functional impairments, and quality of life of critically ill patients admitted to the intensive care unit, as well as identifying the presence of mental health disorders among their families. Additionally, the goal is to identify risk factors that contribute to these functional impairments and reduced quality of life.
Basic objectives2
Others
Basic objectives -Others
The objective is to establish an outpatient follow-up system for critically ill patients and their families, with the aim of clarifying the long-term prognosis, functional impairments, and quality of life of critically ill patients admitted to the intensive care unit, as well as identifying the presence of mental health disorders among their families. Additionally, the goal is to identify risk factors that contribute to these functional impairments and reduced quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-36v2 Japanese Version, EQ-5D-VAS, Pittsburgh Sleep Quality Index, and MoCA-J (Japanese version of the Mini-Mental State Examination) at 1 and 3 months after discharge from the ICU
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 Emergency and Critical Care Center at Osaka University of Medicine and Pharmacy Hospital
Key exclusion criteria
Study participants whom the principal investigator or treating physician has determined are unsuitable for the safe conduct of this study
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
5698686
Address
2-7 daigaku-machi, Takattsuki, Osaka, Japan
TEL
072-684-1221
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
5698686
Address
2-7 daigaku-machi, Takattsuki, Osaka, Japan
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
Osaka Medical and Pharmaceutical 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
Secretariat of the Research Ethics Committee, Osaka University of Medical and Pharmaceutical Sciences
Address
2-7 daigaku-machi, Takattsuki, Osaka, Japan
Tel
072-683-1221
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
| 2026 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
233
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | 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
We provide an explanation of the follow-up outpatient program to patients and their families upon admission to the Emergency and Critical Care Center at Osaka University of Medicine and Pharmacy Hospital.
We schedule outpatient appointments during the patient hospitalization, and patients and their families attend these appointments voluntarily.
Within the scope of routine outpatient care, we assess the patient and their family long-term prognosis, functional impairments, quality of life, and other relevant factors.
Management information
Registered date
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070107
