UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037296
Receipt number R000042521
Scientific Title Effectiveness of VAD Nursing educational program characterized by outcome-based education.
Date of disclosure of the study information 2019/07/06
Last modified on 2019/07/06 19:38:27

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Basic information

Public title

Application and evaluation of outcome-based education into Ventricular Assist Device Nursing educational program.

Acronym

Effectiveness of VAD Nursing educational program characterized by outcome-based education.

Scientific Title

Effectiveness of VAD Nursing educational program characterized by outcome-based education.

Scientific Title:Acronym

Effectiveness of VAD Nursing educational program characterized by outcome-based education.

Region

Japan


Condition

Condition

Nurses working at cardiovascular surgery and cardiology ward.

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effectiveness of the VAD nursing educational program characterized by outcome-based education in nurses working at cardiovascular surgery and cardiology unit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

A difference in total rating scales between pre-intervention period and post-intervention period.

Key secondary outcomes

Changes in rating scales in each category between pre-intervention period and post-intervention period.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

1:In a pre-intervention phase, capabilities of all participants are evaluated by two nurses with specialized knowledge of VAD using rating scales.
2:The participants recieve the educational program for VAD Nursing
3:After the education completes, the above-mentioned evaluations are performed again as a post-intervention phase.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Nurses who work at cardiovascular surgery and cardiology ward.
Nurses who join this education program after getting informed consent.

Key exclusion criteria

A head nurse
VAD Nurses who are rathers
A nurses who is not able to join this education due personal circumstances

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Michiyo
Middle name
Last name Abe

Organization

Tohoku university hospital Nursing division

Division name

East 9 ward

Zip code

980-8574

Address

1-1 Seiryo-machi Aoba-ku Sendai Miyagi

TEL

022-717-7000

Email

akiko-kusakari.b2@tohoku.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Kusakari

Organization

Tohoku university hospital Nursing division

Division name

East 9 ward

Zip code

980-8574

Address

1-1 Seiryo-machi Aoba-ku Sendai Miyagi

TEL

022-717-7000

Homepage URL


Email

akiko-kusakari.b2@tohoku.ac.jp


Sponsor or person

Institute

Tohoku universiy 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

Tohoku university hospital

Address

1-1 Seiryo-machi Aoba-ku Sendai Miyagi

Tel

022-728-4105

Email

rinri-2@proj.med.tohoku.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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2019 Year 07 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


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

2019 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2019 Year 07 Month 06 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 06 Day

Last modified on

2019 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042521


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name