UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045135 |
|---|---|
| Receipt number | R000051562 |
| Scientific Title | A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/08/16 15:19:40 |
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Basic information
Public title
A survey on Advance Care Planning (ACP) for elderly patients admitted urgently to an emergency center and ICU in Niigata Prefecture
Acronym
A survey on Advance Care Planning (ACP) for elderly patients admitted urgently to an emergency center and ICU in Niigata Prefecture
Scientific Title
A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture
Scientific Title:Acronym
A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture
Region
| Japan |
Condition
Condition
Elderly patients admitted urgently to the Emergency Center or ICU in Niigata Prefecture
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the status of ACP acquisition in elderly patients admitted to emergency center and ICU in Niigata Prefecture, and to clarify the relationship between patient background, institutional factors, and social factors (urban and non-urban areas, etc.)
Basic objectives2
Others
Basic objectives -Others
To determine the relationship between ACP acquisition in two periods before and after the COVID-19 pandemic in japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ACP-related information (whether ACP was obtained before or after hospitalization)
Key secondary outcomes
Age, gender, length of stay in the Emergency Center/ICU, length of stay in the hospital, and outcome
ADL before admission, at discharge from the Emergency Center/ICU, and at discharge from the hospital
Pre-existing medical conditions
Presence of invasive treatment and its details
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women aged 75 years and older who were admitted to an emergency room or ICU in Niigata Prefecture
Key exclusion criteria
Patients who refused to give consent
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Natsuo |
| Middle name | |
| Last name | Kamimura |
Organization
Niigata University Medical and Dental Hospital
Division name
Advanced Emergency Medicine and Critical Care Center
Zip code
951-8520
Address
754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-223-6161
8788kanatsu@gmail.com
Public contact
Name of contact person
| 1st name | Natsuo |
| Middle name | |
| Last name | Kamimura |
Organization
Niigata University Medical and Dental Hospital
Division name
Advanced Emergency Medicine and Critical Care Center
Zip code
951-8520
Address
754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
070-5590-4830
Homepage URL
8788kanatsu@gmail.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata 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
IRB of Niigata University
Address
757 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2005
ethics@adm.niigata-u.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
| 2021 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | 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
Participating facilities include Niigata University Medical and Dental Hospital, Niigata Prefectural Niihata Hospital, Niigata City Hospital, Japanese Red Cross Society Nagaoka Red Cross Hospital, Niigata University Regional Medical Education Center Uonuma General Hospital, and Niigata Prefectural Central Hospital.
Patients aged 75 and over who were hospitalized in an emergency will be eligible.
The period will be from October 1, 2019 to December 31, 2019 and October 1, 2020 to December 31, 2020.
Translated with www.DeepL.com/Translator (free version)
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051562
