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Randomized Controlled Trial of Routine Screening for IPV

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ClinicalTrials.gov Identifier: NCT00526994
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : July 31, 2013
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
John H. Stroger Hospital
Information provided by (Responsible Party):
Joanne Klevens, Centers for Disease Control and Prevention

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Quality of Life
Disability
Utilization of Health Care Services
Interventions Other: screened
Behavioral: universal education
Enrollment 2700
Recruitment Details May, 2009-April, 2010 at 10 primary health care clinics in Chicago
Pre-assignment Details 8 Unenrolled: 7 because computer did not save baseline data & 1 Withdrew
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
Period Title: Overall Study
Started 909 893 898
Completed 801 772 791
Not Completed 108 121 107
Reason Not Completed
Lost to Follow-up             98             108             96
Death             4             3             3
Withdrawal by Subject             2             7             5
incarcerated, impaired, incomplete             4             3             3
Arm/Group Title Screened & Referred Universal Education (All Referred) Control Total
Hide Arm/Group Description

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral Total of all reporting groups
Overall Number of Baseline Participants 909 893 898 2700
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 909 participants 893 participants 898 participants 2700 participants
39  (15) 38.3  (14.8) 38.7  (15.1) 38.7  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 909 participants 893 participants 898 participants 2700 participants
Female
909
 100.0%
893
 100.0%
898
 100.0%
2700
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Quality of Life, Physical Health Composite
Hide Description Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
Time Frame at one-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description:

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
Overall Number of Participants Analyzed 801 772 791
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
46.8
(46.1 to 47.4)
46.4
(45.8 to 47.1)
47.2
(46.5 to 47.8)
2.Primary Outcome
Title Quality of Life, Mental Health Composite
Hide Description Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
Time Frame past 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description:

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
Overall Number of Participants Analyzed 801 772 791
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
48.3
(47.5 to 49.1)
48.0
(47.2 to 48.9)
47.8
(47.0 to 48.6)
3.Secondary Outcome
Title Utilization of Health Care
Hide Description number of ambulatory care visits
Time Frame during past year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description:

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
Overall Number of Participants Analyzed 801 772 791
Mean (95% Confidence Interval)
Unit of Measure: visits
5.4
(3.8 to 7.0)
5.7
(4.1 to 7.3)
5.9
(4.3 to 7.4)
4.Secondary Outcome
Title Disability
Hide Description days lost from housework
Time Frame one year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description:

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
Overall Number of Participants Analyzed 801 772 791
Mean (95% Confidence Interval)
Unit of Measure: days
1.9
(1.6 to 2.3)
2.2
(1.8 to 2.5)
1.9
(1.6 to 2.3)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Screened & Referred Universal Education (All Referred) Control
Hide Arm/Group Description

Screened w/4 questions on intimate partner violence; if positive, receives referral information

screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

receives referral information

universal education : receives referral information

no screen and no referral
All-Cause Mortality
Screened & Referred Universal Education (All Referred) Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Screened & Referred Universal Education (All Referred) Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/801 (0.00%)   0/772 (0.00%)   0/791 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Screened & Referred Universal Education (All Referred) Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/801 (0.00%)   0/772 (0.00%)   0/791 (0.00%) 
12% lost to follow-up differed in age, education, and insurance status from those retained. Generalizability of the findings is limited by the urban setting; exclusion of some participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joanne Klevens
Organization: CDC
Phone: 770-488-1386
EMail: dzk8@cdc.gov
Responsible Party: Joanne Klevens, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00526994     History of Changes
Other Study ID Numbers: 200-2006-15969/200-2008-28219
IRB #4984
IRB #4985
OMB # 0920-06BM
Contract #200-2008-28219
& 200-2006-15969
First Submitted: September 6, 2007
First Posted: September 10, 2007
Results First Submitted: February 12, 2013
Results First Posted: July 31, 2013
Last Update Posted: July 31, 2013