UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054140 |
|---|---|
| Receipt number | R000061794 |
| Scientific Title | Identification of determinants of home discharge in elderly patients of convalescent rehabilitation ward. |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2025/05/08 06:44:35 |
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Basic information
Public title
Identification of determinants of home discharge in elderly patients of convalescent rehabilitation ward.
Acronym
Determinants of home discharge for older adults in convalescent rehabilitation.
Scientific Title
Identification of determinants of home discharge in elderly patients of convalescent rehabilitation ward.
Scientific Title:Acronym
Identification of determinants of home discharge in the elderly patients.
Region
| Japan |
Condition
Condition
Proximal femur fracture, other fractures, stroke, cerebral hemorrhage, disuse syndrome, osteoarthritis, spinal stenosis, cervical spondylosis, cervical myelopathy.
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Orthopedics | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of factors determining home discharge of elderly patients in convalescent rehabilitation wards.
Basic objectives2
Others
Basic objectives -Others
Identification of cutoff values for home discharge determinants.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Age, gender, nutritional index CONUT score at admission, MNA-SF at admission, BMI (kg/m2), weight (kg), total cholesterol (TC)
Key secondary outcomes
Identification of cutoff values for factors governing home discharge.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly patients (65 years old and over) admitted and discharged between March 2022 and December 2023 in our convalescent rehabilitation wards.
Key exclusion criteria
Deceased and transferred patients.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Tenjin |
Organization
Shinohara Shonan Clinic Clover Hospital
Division name
Gastroenterology, General Medicine
Zip code
251-0025
Address
3-3-6, Kugenuma Ishigami, Fujisawa-shi, Kanagawa, 251-0025, Japan
TEL
0466-22-7111
7716ttay09170427@gmail.com
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Tenjin |
Organization
Shinohara Shonan Clinic Clover Hospital
Division name
Gastroenterology, General Medicine
Zip code
251-0025
Address
3-3-6, Kugenuma Ishigami, Fujisawa-shi, Kanagawa, 251-0025, Japan
TEL
0466-22-7111
Homepage URL
7716ttay09170427@gmail.com
Sponsor or person
Institute
Shinohara Shonan Clinic Clover Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Shinohara Shonan Clinic Clover Hospital
Address
3-3-6, Kugenuma Ishigami, Fujisawa-shi, Kanagawa, 251-0025, Japan
Tel
0466-22-7111
7716ttay09170427@gmail.com
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
| 2024 | Year | 04 | Month | 12 | 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
357
Results
"The results of this study were presented as a poster at the 14th Annual Meeting of the Japanese Society of Rehabilitation Nutrition (January 25, 2025).
Binary logistic regression analysis identified age, admission CONUT score, and admission MNA-SF score as significant factors associated with discharge to home.
The cutoff value for admission MNA-SF was 7.0 (AUC = 0.695, 95% CI: 0.64,0.749).
Results date posted
| 2025 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 05 | Month | 08 | Day |
Baseline Characteristics
Participants: 357 patients admitted to the convalescent rehabilitation ward.
Age: Mean 81.7(SD7.8) years.
Sex: 129 men (36.1%).
Cognitive impairment: 194 patients (54.3%).
Primary diagnoses:
Proximal femoral fracture: 126 patients (35.3%)
Other fractures: 51 patients (14.3%)
Stroke: 115 patients (32.2%)
Others (each 3.9%): other intracerebral hemorrhage, osteoarthritis, spinal canal stenosis, cervical spondylosis
Disuse syndrome: 23 patients (6.4%)
Nutritional status:
CONUT score: 3.80(SD2.27)
MNA-SF score: 5.6(SD2.65)
FIM scores:
Admission motor FIM: 39.6(SD18.2)
Cognitive FIM: 19.8(SD8.5)
Total FIM: 59.5(SD25.1)
Participant flow
Adverse events
none
Outcome measures
The following seven variables were included as explanatory variables in the logistic regression model
1 Age
2 Sex (male)
3 Admission CONUT score
4 Admission MNA-SF score
5 Body mass index (BMI)
6 Body weight
7 Total cholesterol level.
Plan to share IPD
No plan to share
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 30 | Day |
Other
Other related information
Study design; Observational study
Recruitment of subjects; Patients 65 years old and older admitted to and discharged from theconvalescent rehabilitation wards of the hospital.
Subject recruitment period: March 22, 2024 to August 31, 2024
Measurements: age, gender, presence of dementia, disease proximal femur fracture, other fracture, stroke, other cerebral hemorrhage, disuse syndrome, osteoarthritis, spinal canal stenosis, cervical spondylosis, cervical myelopathy, Height, Weight, CONUT score at admission, MNA-SF at admission, BMI at admission, Motor FIM at admission, Cognitive FIM at admission, Overall FIM at admission, Total cholesterol at admission
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061794
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/05/08 | CHP臨床研究 研究計画書 JARN 川崎2025年1月.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/04/14 | 症例データ仕様書JARN2025.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/04/14 | PDF perfect rihanut multiple imputation20. 01 2023 12 ent.csv |
Single case data URL
Value
https://center6.umin.ac.jp/ice/61794
