UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Acronym	Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Scientific Title	Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Scientific Title:Acronym	Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Region	Japan

Condition
Condition	Domestic violence against women
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness of a face-to-face interview with a self-administered questionnaire for identifying women who are being abused
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification rate of DV
Key secondary outcomes	Comfort level for screening for DV Consulting with a nurse

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Face-to-face interview by nurses
Interventions/Control_2	Self-administered questionnaire
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	Less than 25 weeks pregnancy
Key exclusion criteria	Had any serious mental diseases Not Japanese speaker If their partner would not agree to leave the room during the interview or completing questionnaire
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yaeko Kataoka
Organization	St. Luke's College of Nursing
Division name	Research Center for Development of Nursing Practice
Zip code
Address	10-1 Akashi-cho Chuo-ku Tokyo
TEL	03-6226-6380
Email

Public contact
Name of contact person	1st name Middle name Last name Yaeko Kataoka
Organization	St. Luke's College of Nursing
Division name	Research Center for Development of Nursing Practice
Zip code
Address	10-1 Akashi-cho Chuo-ku Tokyo
TEL	03-6226-6380
Homepage URL
Email	yaeko-kataoka@slcn.ac.jp

Sponsor
Institute	St. Luke's College of Nursing
Institute
Department

Funding Source
Organization	Grant-in-Aid for COE Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2006 Year 03 Month 31 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	For the interview group the identification rate was 32/165 (19.4%) compared with 48/163 (29.4%) in the questionnaire group, which was much higher (relative risk 0.66, 95%CI 0.46 to 0.97).
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	2002 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date	2003 Year 02 Month 01 Day
Last follow-up date	2003 Year 05 Month 01 Day
Date of closure to data entry	2003 Year 05 Month 01 Day
Date trial data considered complete	2003 Year 07 Month 01 Day
Date analysis concluded	2004 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 03 Month 09 Day
Last modified on	2006 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000452

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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