UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055341 |
|---|---|
| Receipt number | R000063180 |
| Scientific Title | Clinical Implementation of Machine Learning System Operation with Discharge Prediction in Patients with Heart Failure |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/09/05 06:53:28 |
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Basic information
Public title
Clinical Implementation of Machine Learning System Operation with Discharge Prediction in Patients with Heart Failure
Acronym
DISCHARGE-HF
Scientific Title
Clinical Implementation of Machine Learning System Operation with Discharge Prediction in Patients with Heart Failure
Scientific Title:Acronym
DISCHARGE-HF
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We developed a machine learning model to predict the start date of hospital discharge adjustment for heart failure patients. In this study, we validate whether the model will contribute to reducing the length of hospital stay when applied to actual clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The model significantly reduces length of hospital stay for heart failure patients compared to heart failure patients in the same period of the previous year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Patients hospitalized with a diagnosis of heart failure by a Board Certified Member of The Japanese Circulation Society after October 2024, when the prediction model will be introduced into clinical practice, who agreed to participate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
he classification will be based on the ACCF/AHA heart failure stage classification, stages C and D. The results of medical examinations by a Board Certified Member of The Japanese Circulation Society will also be used for the classification.
Key exclusion criteria
Cases to be excluded at the time of registration are those that fall into the following criterias.
Patients transferred from other hospitals or departments, or transferred to other departments
Hospitalization for a medical checkup
Cases deemed inappropriate for registration by a Board Certified Member of The Japanese Circulation Society
Cases to be excluded at the time of analysis are those that fall into the following criterias.
Medical hospital stay of 7 days or less
Medical hospital stay of 29 days or more
Discharged due to death
Transfer to another department
Cases deemed inappropriate for analysis by a Board Certified Member of The Japanese Circulation Society
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7153
kazuma.ohyama.e4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Oyama |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7153
Homepage URL
kazuma.ohyama.e4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJITSU
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
11000629
Org. issuing International ID_1
Ethics Committee Tohoku University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院（宮城県）、JA秋田厚生連平鹿総合病院（秋田県）、岩手県立中央病院（岩手県）、岩手県立胆沢病院（岩手県）、気仙沼市立病院（宮城県）、栗原市立栗原中央病院（宮城県）、大崎市民病院（宮城県）、仙台オープン病院（宮城県）、みやぎ県南中核病院（宮城県）、いわき市医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063180
