UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045315 |
|---|---|
| Receipt number | R000051752 |
| Scientific Title | A multicenter prospective cohort study utilizing ICF in elderly patients with heart failure |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2024/03/04 18:33:26 |
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Basic information
Public title
A multicenter prospective cohort study utilizing ICF in elderly patients with heart failure
Acronym
A multicenter cohort ICF study in elderly with heart failure
Scientific Title
A multicenter prospective cohort study utilizing ICF in elderly patients with heart failure
Scientific Title:Acronym
A multicenter cohort ICF study in elderly with heart failure
Region
| Japan |
Condition
Condition
Symptomatic heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the ICF data by a prospective cohort study and to construct a prognostic system for post-discharge prognosis.
Basic objectives2
Others
Basic objectives -Others
This research will lead to the establishment of an information sharing system between medical care and nursing care, the reduction of social security costs through the prevention of heart failure exacerbations, and the development of a prediction system for social security costs and rehospitalization rates through the assessment of life functions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of life at 3 months and 1 year after discharge
Key secondary outcomes
Medical and nursing care costs
Re-admission
nursing care level
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following eligibility criteria and do not meet the exclusion criteria will be eligible for the study among patients with insufficiency aged 75 years or older who are hospitalized at Hiroshima University Hospital and the collaborating research institutions.
Eligibility criteria
Patients admitted to the Department of Cardiology and the Department of Cardiovascular Surgery at the participating institutions with a diagnosis of symptomatic heart failure as the primary or secondary disease.
Those who can provide written consent.
Symptomatic heart failure refers to patients who meet the Framingham heart failure diagnostic criteria or who are judged by the attending physician to have symptoms of low cardiac output syndrome.
Framingham heart failure diagnostic criteria.
Key exclusion criteria
Those who were unable to give consent for this study
Those who are judged by the physician in charge to be incapable of consenting to the study due to impaired consciousness, significant cognitive decline, or higher brain dysfunction.
Those judged by the physician in charge to be incapable of consenting to the study due to consciousness disorder, significant cognitive decline, or higher brain dysfunction
Those who are judged by the physician in
charge to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kimura |
| Middle name | |
| Last name | Hiroaki |
Organization
Hiroshima University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami Ku, Hiroshima City, Hiroshima prefecture, Japan
TEL
0822575566
luna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigehito |
| Middle name | |
| Last name | Shiota |
Organization
Hiroshima University Hospital
Division name
Department of Rehabilitation, Division of Clinical support
Zip code
734-8551
Address
Kasumi 1-2-3, Minami Ku, Hiroshima City, Hiroshima prefecture, Japan
TEL
0822575566
Homepage URL
sshiota@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Janan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
Kasumi 1-2-3,Minami Ku, Hiroshima City, Hiroshima prefecture, Japan
Tel
0822575907
iryo-seisaku@office.hiroshima-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
広島大学病院（広島県），県立広島病院（広島県），三次地区医療センター（広島県），広島共立病院（広島県），アマノリハビリテーション病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 06 | 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
50
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 | 08 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
ICF assessment and measurement of primary and secondary outcomes will be conducted at discharge, 3 months after discharge, and 1 year after discharge. The obtained data will be entered into a database for analysis.
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051752
