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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name