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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000353 |
Receipt No. | R000000452 |
Scientific Title | Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial |
Date of disclosure of the study information | 2006/03/31 |
Last modified on | 2006/03/09 |
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 |
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Condition | ||
Condition | Domestic violence against women | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Less than 25 weeks pregnancy
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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 |
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Target sample size | 280 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 | |
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Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |