UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034882
Receipt number R000039766
Scientific Title Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Date of disclosure of the study information 2018/11/13
Last modified on 2020/12/22 16:36:20

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Basic information

Public title

Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial

Acronym

Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial

Scientific Title

Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial

Scientific Title:Acronym

Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop the E-learning about support for women suffering domestic violence and evaluate the efficacy of the material for obstetric nurse

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in score on the knowledge test on DV and support for women suffering DV between pre and post intervention

Key secondary outcomes

Examine and evaluate the amount of behavior change on the following 4 points between pre and follow-up test:1.Preparation and efforts for improvement on support for women suffering DV 2.Practice and quality of DV screening
3.Practice on support for women suffering DV 4.Practice of self-care when involving support of women suffering DV


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

Provide the E-learning about support for women suffering DV to the intervention group for a month

Interventions/Control_2

Provide nothing to the control group

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

Female

Key inclusion criteria

Female registered nurse, licensed practical nurse ,and midwife engaging in care for pregnant and parturient women at hospital, obstetric clinic and maternity home in Japan

Key exclusion criteria

Engaged only in care for newborn and not engaged in care for pregnant and parturient women

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Naoko
Middle name
Last name Maruyama

Organization

Graduate school of St Luke's international university

Division name

Nursing Studies, Doctoral course

Zip code

104-0044

Address

10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3543-6391

Email

16DN013@slcn.ac.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Maruyama

Organization

Graduate school of St Luke's international university

Division name

Nursing Studies, Doctoral course

Zip code

104-0044

Address

10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3543-6391

Homepage URL


Email

16DN013@slcn.ac.jp


Sponsor or person

Institute

Graduate school of St Luke's international university

Institute

Department

Personal name



Funding Source

Organization

Yamaji Fumiko Nursing Research Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

MEXT(Japan), JSPS KAKENHI Grant-in-Aid for
Scientific Research(B)Number
18H03099 Principal Investigator:Yaeko Kataoka


IRB Contact (For public release)

Organization

St Luke's International University Research Ethics Committee

Address

10-1 Akashi-cho Chuo-ku Tokyo 104-0044 Japan

Tel

03-3541-5151

Email

kenkyukikaku@luke.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



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 13 Day


Related information

URL releasing protocol

Not yet officially announced

Publication of results

Published


Result

URL related to results and publications

https://mol.medicalonline.jp/archive/search?jo=cu2mater&ye=2020&vo=61&issue=3

Number of participants that the trial has enrolled

88

Results

Basic data and the knowledge score (112 perfect score) at pretest were not different between the intervention group(n=45) and the control group(n=43). For the post1test, the IG had a mean change in knowledge score of 7.7 points with the siginificant difference of 1.4 points compared to the CG. The change between pre and post2test was significantly larger in the IG (7.0 points) compared to the CG (1.3 points) and in the IG, the change between post1 and post2test was no different.

Results date posted

2020 Year 12 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Average age:38 years old, The mean years of experience of perinatal care: 11.7 years, 80% of the participants have the qualification of a midwife

Participant flow

41 of the IG and 38 of the CG completed the pretest. 37 of the IG and 37 of the CG completed the pre and post1test. Follow up rate until post1test was 84.1 percent. 34 of the IG and 34 of the CG completed pre, post1, and post2test. Follow up rate until post2test was 77.3 percent.

Adverse events

Nothing

Outcome measures

Primary outcome
The mean change in knowledge score about DV

Secondary outcome
The number of types of implemented preparatory/reinforcing behaviors for implementing support for victims of DV, The implementation rate of DV screening and of the support to pregnant and parturient women who may be victims of DV, The implementation status of self-care of providers.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 16 Day

Date of IRB

2018 Year 08 Month 23 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2019 Year 09 Month 09 Day

Date of closure to data entry

2019 Year 09 Month 09 Day

Date trial data considered complete

2020 Year 04 Month 30 Day

Date analysis concluded

2020 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 13 Day

Last modified on

2020 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039766


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name