Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 3:35 PM
Study NCT ID:
NCT00526994
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2007-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled Trial of Routine Screening for IPV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dzk8@cdc.gov', 'phone': '770-488-1386', 'title': 'Joanne Klevens', 'organization': 'CDC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information', 'otherNumAtRisk': 801, 'otherNumAffected': 0, 'seriousNumAtRisk': 801, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information', 'otherNumAtRisk': 772, 'otherNumAffected': 0, 'seriousNumAtRisk': 772, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'no screen and no referral', 'otherNumAtRisk': 791, 'otherNumAffected': 0, 'seriousNumAtRisk': 791, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life, Physical Health Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}, {'value': '791', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'OG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'OG002', 'title': 'Control', 'description': 'no screen and no referral'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '47.4'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '47.1'}, {'value': '47.2', 'groupId': 'OG002', 'lowerLimit': '46.5', 'upperLimit': '47.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at one-year follow-up', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Utilization of Health Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}, {'value': '791', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'OG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'OG002', 'title': 'Control', 'description': 'no screen and no referral'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '7.0'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '7.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during past year', 'description': 'number of ambulatory care visits', 'unitOfMeasure': 'visits', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}, {'value': '791', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'OG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'OG002', 'title': 'Control', 'description': 'no screen and no referral'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.3'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.5'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year follow-up', 'description': 'days lost from housework', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Life, Mental Health Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}, {'value': '791', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'OG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'OG002', 'title': 'Control', 'description': 'no screen and no referral'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '49.1'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '48.9'}, {'value': '47.8', 'groupId': 'OG002', 'lowerLimit': '47.0', 'upperLimit': '48.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'past 30 days', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'FG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'FG002', 'title': 'Control', 'description': 'no screen and no referral'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '909'}, {'groupId': 'FG001', 'numSubjects': '893'}, {'groupId': 'FG002', 'numSubjects': '898'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '801'}, {'groupId': 'FG001', 'numSubjects': '772'}, {'groupId': 'FG002', 'numSubjects': '791'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '107'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'incarcerated, impaired, incomplete', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'May, 2009-April, 2010 at 10 primary health care clinics in Chicago', 'preAssignmentDetails': '8 Unenrolled: 7 because computer did not save baseline data \\& 1 Withdrew'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'BG000'}, {'value': '893', 'groupId': 'BG001'}, {'value': '898', 'groupId': 'BG002'}, {'value': '2700', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Screened & Referred', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information\n\nscreening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information'}, {'id': 'BG001', 'title': 'Universal Education (All Referred)', 'description': 'receives referral information\n\nuniversal education : receives referral information'}, {'id': 'BG002', 'title': 'Control', 'description': 'no screen and no referral'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '15', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '15.1', 'groupId': 'BG002'}, {'value': '38.7', 'spread': '14.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '909', 'groupId': 'BG000'}, {'value': '893', 'groupId': 'BG001'}, {'value': '898', 'groupId': 'BG002'}, {'value': '2700', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2007-09-06', 'resultsFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2007-09-06', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-29', 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life, Physical Health Composite', 'timeFrame': 'at one-year follow-up', '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.'}, {'measure': 'Quality of Life, Mental Health Composite', 'timeFrame': 'past 30 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Utilization of Health Care', 'timeFrame': 'during past year', 'description': 'number of ambulatory care visits'}, {'measure': 'Disability', 'timeFrame': 'one year follow-up', 'description': 'days lost from housework'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intimate partner violence', 'domestic violence', 'spouse abuse', 'screening'], 'conditions': ['Quality of Life', 'Disability', 'Utilization of Health Care Services']}, 'referencesModule': {'references': [{'pmid': '26241603', 'type': 'DERIVED', 'citation': 'Klevens J, Sadowski LS, Kee R, Garcia D, Lokey C. Effect of Screening for Partner Violence on Use of Health Services at 3-Year Follow-up of a Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):515-6. doi: 10.1001/jama.2015.6755. No abstract available.'}, {'pmid': '22893165', 'type': 'DERIVED', 'citation': "Klevens J, Kee R, Trick W, Garcia D, Angulo FR, Jones R, Sadowski LS. Effect of screening for partner violence on women's quality of life: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):681-9. doi: 10.1001/jama.2012.6434."}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.', 'detailedDescription': "Approximately 2675 women\\* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life (SF-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed 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); disability; and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.\n\n\\*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women attending obstetrics \\& gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic\n\nExclusion Criteria:\n\n* non-English speaking other than Spanish speakers\n* accompanied by a child \\>3 years of age without adequate provision for child care;\n* Visually- or hearing-impaired women;\n* without access to a telephone;\n* Severe Mental impairment'}, 'identificationModule': {'nctId': 'NCT00526994', 'briefTitle': 'Randomized Controlled Trial of Routine Screening for IPV', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Randomized Controlled Trial of Routine Screening for Intimate Partner Violence', 'orgStudyIdInfo': {'id': '200-2006-15969/200-2008-28219'}, 'secondaryIdInfos': [{'id': 'IRB #4984'}, {'id': 'IRB #4985'}, {'id': 'OMB # 0920-06BM'}, {'id': 'Contract #200-2008-28219'}, {'id': '& 200-2006-15969'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screened', 'description': 'Screened w/4 questions on intimate partner violence; if positive, receives referral information', 'interventionNames': ['Other: screened']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Universal education', 'description': 'all participants receive partner violence referral information', 'interventionNames': ['Behavioral: universal education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no screen and no referral'}], 'interventions': [{'name': 'screened', 'type': 'OTHER', 'description': 'Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information', 'armGroupLabels': ['Screened']}, {'name': 'universal education', 'type': 'BEHAVIORAL', 'description': 'receives referral information', 'armGroupLabels': ['Universal education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fantus Health clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Joanne Klevens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Cook County Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'epidemiologist', 'investigatorFullName': 'Joanne Klevens', 'investigatorAffiliation': 'Centers for Disease Control and Prevention'}}}}