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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00336297
Other study ID # MacMillan_VAW_Testing_Trial
Secondary ID
Status Completed
Phase N/A
First received June 9, 2006
Last updated November 28, 2006
Start date May 2004
Est. completion date February 2005

Study information

Verified date February 2005
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through screening -- either universal or indicator-based is effective in preventing or ameliorating important outcomes. This is a critical first step in developing a larger randomized controlled trial (RCT) which examines the effectiveness of screening in preventing woman abuse, improving quality of life and other associated outcomes. This study prepares for the RCT by testing the optimal method of administration for the two screening instruments that will be used in the RCT. The administration formats are: computer-based screen, paper and pencil screen and face-to-face screen. They study will also determine recruitment rates.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Women aged 18-64 years

- Patients at the health care site

- Able to participate in English

- Able to separate from accompanying person(s)

Exclusion Criteria:

- Too ill to participate

- Unable to separate from accompanying person(s)

- Unable to speak, read, or write English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Woman Abuse Screening Tool

Partner Violence Screen

Computerized screening

Face to face screening

Written screening on forms


Locations

Country Name City State
Canada Cambridge Memorial Hospital - Emergency Department Cambridge Ontario
Canada Carlisle Medical Centre Carlisle Ontario
Canada City of Hamilton Public Health and Community Services Department Hamilton Ontario
Canada Hamilton Health Sciences Colposcopy Clinic Hamilton Ontario
Canada London Health Sciences - Victoria Hospital Clinic 5A London Ontario
Canada Victoria Family Medical Centre London Ontario
Canada Norfolk General Hospital - Emergency Department Simcoe Ontario

Sponsors (2)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation Ontario Women’s Health Council

Country where clinical trial is conducted

Canada, 

References & Publications (1)

MacMillan HL, Wathen CN, Jamieson E, Boyle M, McNutt LA, Worster A, Lent B, Webb M; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006 Aug 2;296(5): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary disclosure rates for past year exposure to intimate partner violence
Secondary participant satisfaction with completing the instruments
Secondary missing data
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