Intimate Partner ViolenceNCT02937493
Intimate Partner Violence and a New Screening Score - a Prospective Observational Study Over Eight Years
An observational study of Intimate Partner Violence, run by Medical University of Vienna.
Trial summary
A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Lunar phases
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 351,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, have been considered eligible for inclusion. Out of this patient population a total of 1.406 cases associated with IPV have been consecutively and prospectively included in our in-house screening service for IPV cases. Data collection was performed prospectively and statistical evaluation was performed retrospectively. 40 individuals had to be excluded due to missing data resulting in 1.366 individuals that were included in our analysis. The IPV in-house screening service was established in 2008, and our Department represents a leading figure in detection and servicing victims of domestic violence. Our IPV in-house screening service is a routine procedure established 24/7 at clinics for all admitted patients.
Who may be able to join
- Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch) [45]. In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.
Who cannot join
- If other than inclusion
About this study
A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out of this patient population a total of 1.406 cases associated with IPV have been consecutively and prospectively included in our in-house screening service for IPV cases. Data collection was performed prospectively and statistical evaluation was performed retrospectively, approved by local IRB (1453/2016).
Read the detailed description
All cases with association to IPV during inclusion period. 40 individuals had to be excluded due to missing data resulting in 1.366 individuals that were included in our analysis. Patients were identified from hospital in-patient enquiry system and in-house screening service for IPV. The IPV in-house screening service was established in 2008, and our Department represents a leading figure in detection and servicing victims of domestic violence. Our IPV in-house screening service is a routine procedure established 24/7 at clinics for all admitted patients.
If the slightest suspicion rose up, patients were asked by the attending physician or nurse, in a private and respectful manner, if a certainty of IPV exists, related to the actual presentation. If the patient admits the fact of IPV, this is noted in the hospital in-patient enquiry system, and a notification is sent to the local police station - as required by Austrian law. Part of our IPV in-house screening service, is the admission to the victim protection program and photographic documentation for legal utilization on behalf of the victim in an upcoming law claim, both services can be joined voluntarily by the victims.
Classification of migration background Patients´ clinical and demographic data were retrieved from our database. Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.
The reason for using German law in an Austrian study is justified by a more practical and veridical approach of the German law in this particular matter. The corresponding Austrian law for defining migration background is almost identical, except for (3), where compared to Germany both parents have to be affected instead of one. The reason for explaining this matter in such a detail is to avoid any misleading conclusions, based on false assumptions.
Study population was divided into the following sub-groups: patients with migration background (MB), and patients without migration background (NMB), according to data retrieved from patient's medical records and inclusion criteria.
Classification of lunar phases Adjustment of our dataset according to lunar phases was performed in collaboration with the Central Institute for Meteorology and Geodynamics (Zentralanstalt für Meteorologie und Geodynamik, ZAMG), Vienna, Austria.
Classification of socioeconomic status Socioeconomic status of the victim was assumed according to their zip code in correlation with a data adjustment with Statistics Austria, Vienna, Austria. The 23 districts of Vienna were subdivided in three groups: rich, middle class, and poor, according to data from Statistics Austria and government reports. Rich was defined as > 110% of average income; middle class 90-110% of average income; and poor <90% of average income; Districts for "rich" were considered: 1., 4., 7., 13., 18., 19., 23.; Middle class: 2., 3., 6., 9., 11., 14., 17., 21., 22.; Poor: 5., 10., 12., 15., 16., 20.; Outcome measurement The primary outcome measured was the association between migration background and IPV.
Acceptance of the victim protection program and photographic documentation, relationship between the occurrence of IPV and moon´s phase, significant linkage between poverty and IPV, and other epidemiological facts were also observed.
RIPV score implementation Based on our hypothesis for possible influencing factors and existing findings in the literature, we generated the RIPV score to detect possible IPV victims in the ED [5,9,11,35,38]. The score is characterised by 8 simple questions and covers the most prominent factors associated with IPV in women. Therefore the 8 questions are: 1. Is there any history of IPV? 2. Is there a substance abuse in your environment? 3. Is there a migration background? 4. Is there a poor socioeconomic status? 5. Absent moon? 6. Are you pregnant? /. Female gender? 8. Age below 35 years? This score was retrospectively utilized in our study population to proof its possible effectiveness. (Table 2)
Statistical analysis For statistical analyses we used the SPSS 16.0 software package (SPSS, Chicago, Ill., USA). Mean value and standard error of the mean were given unless otherwise indicated for continuous variables. Discrete data are presented as counts and percentages. A two-tailed p-value < 0.05 was considered statistically significant.
- Conditions
- Intimate Partner Violence
- Being tested
- Lunar phases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunar phasesBehavioural
Observation if lunar phases had an influence on occurrence of IPV
| Study group | Role | What they receive |
|---|---|---|
| Migration Background | Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949. Receives: Behavioral: Lunar phases | |
| Non Migration Background | If the following criteria is not fulfilled: Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949. Receives: Behavioral: Lunar phases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lunar Phases
Adjustment for dataset according to lunar phases was performed with the data provided by the Central Institute for Meteorology and Geodynamics, Vienna, Austria.
Measured: 01/2008 - 12/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Florian M Kovar, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937493
- Sponsor's protocol ID
- IPV
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intimate Partner Violence and a New Screening Score - a Prospective Observational Study Over Eight Years
- ClinicalTrials.gov ID
- NCT02937493
- Acronym / sponsor ID
- IPV
- Conditions
- Intimate Partner Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351,000 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out of this patient population a total of 1.406 cases associated with IPV have been consecutively and prospectively included in our in-house screening service for IPV cases. Data collection was performed prospectively and statistical evaluation was performed retrospectively, approved by local IRB (1453/2016).
Detailed description
All cases with association to IPV during inclusion period. 40 individuals had to be excluded due to missing data resulting in 1.366 individuals that were included in our analysis. Patients were identified from hospital in-patient enquiry system and in-house screening service for IPV. The IPV in-house screening service was established in 2008, and our Department represents a leading figure in detection and servicing victims of domestic violence. Our IPV in-house screening service is a routine procedure established 24/7 at clinics for all admitted patients.
If the slightest suspicion rose up, patients were asked by the attending physician or nurse, in a private and respectful manner, if a certainty of IPV exists, related to the actual presentation. If the patient admits the fact of IPV, this is noted in the hospital in-patient enquiry system, and a notification is sent to the local police station - as required by Austrian law. Part of our IPV in-house screening service, is the admission to the victim protection program and photographic documentation for legal utilization on behalf of the victim in an upcoming law claim, both services can be joined voluntarily by the victims.
Classification of migration background Patients´ clinical and demographic data were retrieved from our database. Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.
The reason for using German law in an Austrian study is justified by a more practical and veridical approach of the German law in this particular matter. The corresponding Austrian law for defining migration background is almost identical, except for (3), where compared to Germany both parents have to be affected instead of one. The reason for explaining this matter in such a detail is to avoid any misleading conclusions, based on false assumptions.
Study population was divided into the following sub-groups: patients with migration background (MB), and patients without migration background (NMB), according to data retrieved from patient's medical records and inclusion criteria.
Classification of lunar phases Adjustment of our dataset according to lunar phases was performed in collaboration with the Central Institute for Meteorology and Geodynamics (Zentralanstalt für Meteorologie und Geodynamik, ZAMG), Vienna, Austria.
Classification of socioeconomic status Socioeconomic status of the victim was assumed according to their zip code in correlation with a data adjustment with Statistics Austria, Vienna, Austria. The 23 districts of Vienna were subdivided in three groups: rich, middle class, and poor, according to data from Statistics Austria and government reports. Rich was defined as > 110% of average income; middle class 90-110% of average income; and poor <90% of average income; Districts for "rich" were considered: 1., 4., 7., 13., 18., 19., 23.; Middle class: 2., 3., 6., 9., 11., 14., 17., 21., 22.; Poor: 5., 10., 12., 15., 16., 20.; Outcome measurement The primary outcome measured was the association between migration background and IPV.
Acceptance of the victim protection program and photographic documentation, relationship between the occurrence of IPV and moon´s phase, significant linkage between poverty and IPV, and other epidemiological facts were also observed.
RIPV score implementation Based on our hypothesis for possible influencing factors and existing findings in the literature, we generated the RIPV score to detect possible IPV victims in the ED [5,9,11,35,38]. The score is characterised by 8 simple questions and covers the most prominent factors associated with IPV in women. Therefore the 8 questions are: 1. Is there any history of IPV? 2. Is there a substance abuse in your environment? 3. Is there a migration background? 4. Is there a poor socioeconomic status? 5. Absent moon? 6. Are you pregnant? /. Female gender? 8. Age below 35 years? This score was retrospectively utilized in our study population to proof its possible effectiveness. (Table 2)
Statistical analysis For statistical analyses we used the SPSS 16.0 software package (SPSS, Chicago, Ill., USA). Mean value and standard error of the mean were given unless otherwise indicated for continuous variables. Discrete data are presented as counts and percentages. A two-tailed p-value < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migration Background | – | Behavioral: Lunar phasesMigration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949. |
| Non Migration Background | – | Behavioral: Lunar phasesIf the following criteria is not fulfilled: Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, have been considered eligible for inclusion. Out of this patient population a total of 1.406 cases associated with IPV have been consecutively and prospectively included in our in-house screening service for IPV cases. Data collection was performed prospectively and statistical evaluation was performed retrospectively. 40 individuals had to be excluded due to missing data resulting in 1.366 individuals that were included in our analysis. The IPV in-house screening service was established in 2008, and our Department represents a leading figure in detection and servicing victims of domestic violence. Our IPV in-house screening service is a routine procedure established 24/7 at clinics for all admitted patients.
Key inclusion criteria (1 listed)
- Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch) [45]. In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.
Key exclusion criteria (1 listed)
- If other than inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lunar phasesObservation if lunar phases had an influence on occurrence of IPV | Behavioural | Migration Background, Non Migration Background |
Primary outcome
Lunar Phases
Time frame: 01/2008 - 12/2015
Adjustment for dataset according to lunar phases was performed with the data provided by the Central Institute for Meteorology and Geodynamics, Vienna, Austria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intimate Partner Violence, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lunar Phases (time frame: 01/2008 - 12/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.