UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049001 |
|---|---|
| Receipt number | R000055822 |
| Scientific Title | Efficacy of the Improvement Program for ICU Delirium Patients with Post Intensive Care Syndrome |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2025/09/25 09:43:21 |
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Basic information
Public title
Efficacy of the Post Intensive Care Syndrome program
Acronym
Efficacy of the Post Intensive Care Syndrome program
Scientific Title
Efficacy of the Improvement Program for ICU Delirium Patients with Post Intensive Care Syndrome
Scientific Title:Acronym
Efificacy of the PICS care program
Region
| Japan |
Condition
Condition
Delirium patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a care program including cognitive training for PICS patients with ICU delirium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-36 at 3, 6, and 12 months after discharge
Key secondary outcomes
Mental impairment (HADS), cognitive impairment (MoCA-J), and physical impairment(6MWT) at 3, 6, and 12 months after discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
participate in a cognitive intervention program in addition to the regular cardiac rehabilitations (15 minutes)
Interventions/Control_2
Not participating in cognitive intervention program
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ICU delirium patients with cardiovascular disease
Key exclusion criteria
1) Leave the Intensive Care Unit within 6 hours
2) Age 20 years or more
3) Coma
4)Difficulty communicating in Japanese
5) In-hospital death or Death during intervention
6) visually impaired patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | chikayo |
| Middle name | |
| Last name | yamada |
Organization
Kansai Medical university
Division name
Faculty of Nursing
Zip code
573-1004
Address
2-2-2.Shinmachi Hirakata Osaka
TEL
072-804-0101
yamadac@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | chikayo |
| Middle name | |
| Last name | yamada |
Organization
Kansai Medical University
Division name
Faculty of Nursing
Zip code
5731004
Address
2-2-2.Shinmachi Hirakata Osaka
TEL
072-804-0101
Homepage URL
yamada.cxb@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Chikayo Yamada
Funding Source
Organization
Grants-in-Aid for Scientific Reserch(C)
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
Kyoto Prefectural University of Medicine
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
Tel
0752515111
ychikayo@koto.kpu-m.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
| 2022 | Year | 09 | Month | 22 | 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 | 09 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055822
