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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037430
Receipt No. R000042554
Scientific Title Effect of Frailty on Elderly Patients Receiving Intensive Care: Prospective Multicenter Observational Study
Date of disclosure of the study information 2019/07/21
Last modified on 2019/11/03

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Basic information
Public title Prognosis and QOL Study on Elderly Patients Receiving Intensive Care
Acronym LIFE (Looking into Intensive care setting on Frailty of Elderly) study
Scientific Title Effect of Frailty on Elderly Patients Receiving Intensive Care: Prospective Multicenter Observational Study
Scientific Title:Acronym LIFE (Looking into Intensive care setting on Frailty of Elderly) study
Region
Japan

Condition
Condition Patients recieving intesive care.
Patients aged over 65.
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study is designed to clarify the prognosis and quality of life after emergency intensive care for elderly patients in Japan. Effect of frailty on prognosis, quality of life, and activity of daily living are examined.
Basic objectives2 Others
Basic objectives -Others Effect of frailty on elderly patients receiving intensive care.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Six month survival according to each frailty.
Key secondary outcomes 1. Twenty-eight day survival according to each frailty.
2. Quality of life six months after admission and the change according to each frailty.
3. Activity of daily living six months after admission and the change according to each frailty.
4. Location (other facility/home) after intensive care according to each frailty.
5. Total medical expenses according to each frailty.

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients who met the following criteria in 3 month period.
1. Patients who visited the emergency rooms of the participating facilities. to the intensive care unit of the participating facilities though the emergency rooms.
2. Patients who admitted directory to the intensive care unit though the emergency rooms.
3. Patients who are aged 65 and over 65.
Key exclusion criteria Patients with missing Clinical Frailty Scale before the transport.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hiromichi
Middle name
Last name Naito
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Emergency, Critical Care, and Disaster Medicine
Zip code 700-8558
Address 2-5-1 Shikatacho, Kitaku, Okayama
TEL 086-235-7427
Email naito05084@gmail.com

Public contact
Name of contact person
1st name Mototaka
Middle name
Last name Inaba
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Emergency, Critical Care, and Disaster Medicine
Zip code 700-8558
Address 2-5-1 Shikatacho, Kitaku, Okayama
TEL 086-235-7427
Homepage URL
Email pau546oq@s.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences,
Department of Emergency, Critical Care, and Disaster Medicine
Institute
Department

Funding Source
Organization Ministry of education
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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikatacho, Kitaku, Okayama
Tel 086-235-6938
Email mae6605@adm.okayama-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
2019 Year 07 Month 21 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
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 03 Month 08 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observations will be conducted for the following data and responses to the questionnaires.
1. Participating facility information
2. Patient characteristics
3. Treatment
4. Severity
5. Outcome
6. Questionnaires including frailty scale and quality of life at admission
7. Questionnaires including quality of life six month after admission

Management information
Registered date
2019 Year 07 Month 20 Day
Last modified on
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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