UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037430 |
|---|---|
| Receipt number | 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 | 2023/04/12 14:14:20 |
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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
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
pau546oq@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences,
Department of Emergency, Critical Care, and Disaster Medicine
Institute
Department
Personal name
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
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
https://okayama-u-qq.sakura.ne.jp/research
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-32519-2
Number of participants that the trial has enrolled
650
Results
955 cases were screened for eligibility, 650 was included in the study. The median age was 79 (IQR 72-85) years. Overall mortality at 6-month was 21% ranging from CFS1: 6.2% to CFS>7: 42.9%. Six-month mortality increased with higher CFS. CFS was an independent prognostic factor (one-point increase in CFS, adjusted RR: 1.19 [1.09 - 1.30]). Quality of life (EQ5D index and VAS) worsened with higher CFS. Proportion of patients who could directly discharge home decreased with higher CFS.
Results date posted
| 2022 | Year | 02 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 79 (IQR 72-85) years, 58.5% were male. 84.3% of the patients lived home without assistance before admission, and 6.8% were living at home with service. The remaining 6.5% of the patients were admitted from nursing homes. The median Charlson Comorbidity Index (CCI) was 5 (4-6) and the median CFS was 3 (3-5). Frailty (CFS>4) was observed in 26.6% of patients. The median APACHE2 score was 22 (16-29).
Participant flow
Patients were enrolled from 19 participating centers in Japan during four consecutive months for each facility between November 2019 and April 2020. 955 cases were screened for eligibility, after excluding the patients, 650 were included in the study. Quality of life using the EQ5D were available in 534 patients.
Adverse events
nothing in particular
Outcome measures
Primary endpoint: 6-month mortality by CFS
Secondary endpoints:
EQ5D index by CFS.
Rate of discharges to patient housing by CFS
Total medical costs by CFS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042554
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/28 | 研究計画書v5.0_200930.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/07/28 | 症例・除外基準191009.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
