UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022064
Receipt number R000024164
Scientific Title Investigation of care environment, self-care behavior and QOL in patients with chronic heart failure, with Certified Nurse in chrnic heart failure nursing.
Date of disclosure of the study information 2016/04/26
Last modified on 2018/08/06 19:44:39

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Basic information

Public title

Investigation of care environment, self-care behavior and QOL in patients with chronic heart failure, with Certified Nurse in chrnic heart failure nursing.

Acronym

Investigation of care environment, self-care behavior and QOL in patients with chronic heart failure.

Scientific Title

Investigation of care environment, self-care behavior and QOL in patients with chronic heart failure, with Certified Nurse in chrnic heart failure nursing.

Scientific Title:Acronym

Investigation of care environment, self-care behavior and QOL in patients with chronic heart failure.

Region

Japan


Condition

Condition

chronic heart failure

Classification by specialty

Cardiology Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between care environment and cardiovascular events in heart failure patients.

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between care environment and heart failure self-care behavior and quality of life in heart failure patients.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

-Hospitalization for heart failure
-Heart failure death

Key secondary outcomes

-Quality of life
-Heart failure Self-care behavior


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hospitalized and survived patients with heart failure at discharge New York Heart Association classification 1-3degrees.

Key exclusion criteria

- less than 20 years old
- Acute coronary syndrome
- End-stage renal failure ( dialysis patients )
- serious co-morbidities that may affect endpoints
- patients who can not answer to questionnaire.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihito Sato

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.

TEL

06-6480-7000

Email

yukihito.sato@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Washida

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Department of Nurse

Zip code


Address

Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.

TEL

06-6480-7000

Homepage URL


Email

koichi.w0130@gmail.com


Sponsor or person

Institute

Hyogo Prefectural Amagasaki General Medical Center

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


Address


Tel


Email



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

兵庫県立尼崎総合医療センター


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 26 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

No longer recruiting

Date of protocol fixation

2015 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 23 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information

To investigation of care environment , self-care behavior , quality of life with heart failure patients.


Management information

Registered date

2016 Year 04 Month 26 Day

Last modified on

2018 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024164


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name