Spouse AbuseSWIFTNCT04829474
Severe Women Injury Factors Test (SWIFT)
An observational study of Spouse Abuse, run by Centre Hospitalier Régional d'Orléans at 5 sites in France.
Trial summary
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spouse Abuse
- What is being tested?
- Survey
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Mar 2021to 23 Jul 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women consulting a doctor for intimate partner violence
Who may be able to join
- Adult patients
- Admission to emergency for intimate partner violence
- Or consultation to SOS doctor for intimate partner violence
- Or consultation to medico-judicial unit for intimate partner violence
- No verbal opposition to inclusion
Who cannot join
- Non intimate partner violence
- Patient under guardianship or curatorship
- Non French speaker
- Coma or inability to express non-opposition
- Prior participation in another center
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Regional Hospital center of Orleans
Orléans, 45067
Centre Hospitalier Régional d'Orléans (UMJ)
Orléans
CHRU de Tours (SAU)
Tours
CHRU de Tours (UMJ)
Tours
SOS Médecins Tours
Tours
About this study
Official title: Descriptive Factors of Intimate Partner Violence on Women Related to "Incapacité Totale de Travail" : Multicenter Prospective Study
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.
Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.
Read the detailed description
Routine screening is recommended with redaction of medical certificate in which doctor have to determine l'"Incapacité Totale de Travail" corresponding to the duration of discomfort (physical and psychological repercussions) in the activities of daily life.
It is a legal notion allows to rule on the responsibility of the author. The sentence is increased if the ITT is greater than 8 days.
Worldwide, 30% of women suffered violence whose most common form is intimate partner violence, but legal proceedings have been initiated in less than 25% of the cases.
The trauma of women victims of domestic violence worsens with the repetitions of assaults.
The investigators suppose that the duration of ITT is an indicator of the severity of the injuries sustained.
So, the investigators want to highlight the socio-demographic characteristics and describe the spouse abuse, and then related theese factors to " Incapacité Totale de Travail " (term used in law. It is a scale for assessing the importance of injuries).
- Conditions
- Spouse Abuse
- Being tested
- Survey
- Keywords
- Intimate partner violence, Descriptive factors, "Incapacité Totale de travail"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
It is a survey that the patient and doctor must complete.
| Study group | Role | What they receive |
|---|---|---|
| Women consulting for spouse abuse | The study focuses on women consulting a doctor as part of spouse abuse, whatever the context (at the request of the police or not) or their motivation (medical or social). Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive factors of intimate partner violence on women related to "Incapacité Totale de Travail"
Highlight the socio-demographic characteristics and the violence suffered by women victims of intimate partner violence, and related this factors to " Incapacité Totale de travail "
Measured: Month 24
Secondary outcomes (2)
Descriptive factors of intimate partner violence on women related to "Incapacité Totale de travail" for more than eight days.
Highlight the socio-demographic characteristics and the violence suffered by women victims of intimate partner violence, and related this factors to an " Incapacité Totale de travail " for more than eight days.
Measured: Month 24
Spontaneus request of a medical certificate during the consultation.
Determine the proportion of women asking for a medical certificate during the consultation.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start8 Mar 2021
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
Why it stopped: recruitment is insufficient and the current context does not allow satisfactory data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spouse AbuseStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien PASSERIEUX, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829474
- Sponsor's protocol ID
- CHRO-2021-02
- Acronym
- SWIFT
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leppakoski T, Paavilainen E, Astedt-Kurki P. Experiences of emergency care by the women exposed to acute physical intimate partner violence from the Finnish perspective. Int Emerg Nurs. 2011 Jan;19(1):27-36. doi: 10.1016/j.ienj.2010.02.006. Epub 2010 May 20.
PubMed 21193165Saberi E, Eather N, Pascoe S, McFadzean ML, Doran F, Hutchinson M. Ready, willing and able? A survey of clinicians' perceptions about domestic violence screening in a regional hospital emergency department. Australas Emerg Nurs J. 2017 May;20(2):82-86. doi: 10.1016/j.aenj.2017.02.001. Epub 2017 Mar 6.
PubMed 28279677Lopez-Ossorio JJ, Gonzalez Alvarez JL, Buquerin Pascual S, Garcia LF, Buela-Casal G. Risk factors related to intimate partner violence police recidivism in Spain. Int J Clin Health Psychol. 2017 May-Aug;17(2):107-119. doi: 10.1016/j.ijchp.2016.12.001. Epub 2017 Jan 31.
PubMed 30487886Lyons VH, Kernic MA, Rowhani-Rahbar A, Holt VL, Carone M. Use of multiple failure models in injury epidemiology: a case study of arrest and intimate partner violence recidivism in Seattle, WA. Inj Epidemiol. 2019 Aug 12;6:36. doi: 10.1186/s40621-019-0215-x. eCollection 2019.
PubMed 31417842Choi AW, Lo BC, Wong JY, Lo RT, Chau PC, Wong JK, Lau CL, Kam CW. Clinical Features of Heterosexual Intimate Partner Violence Victims With Escalating Injury Severity. J Interpers Violence. 2021 Sep;36(17-18):8585-8605. doi: 10.1177/0886260519850539. Epub 2019 May 29.
PubMed 31140351
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Factors of Intimate Partner Violence on Women Related to "Incapacité Totale de Travail" : Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04829474
- Acronym / sponsor ID
- SWIFT / CHRO-2021-02
- Conditions
- Spouse Abuse
- Keywords
- Intimate partner violence, Descriptive factors, "Incapacité Totale de travail"
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment is insufficient and the current context does not allow satisfactory data collection
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- 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.
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.
Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.
Detailed description
Routine screening is recommended with redaction of medical certificate in which doctor have to determine l'"Incapacité Totale de Travail" corresponding to the duration of discomfort (physical and psychological repercussions) in the activities of daily life.
It is a legal notion allows to rule on the responsibility of the author. The sentence is increased if the ITT is greater than 8 days.
Worldwide, 30% of women suffered violence whose most common form is intimate partner violence, but legal proceedings have been initiated in less than 25% of the cases.
The trauma of women victims of domestic violence worsens with the repetitions of assaults.
The investigators suppose that the duration of ITT is an indicator of the severity of the injuries sustained.
So, the investigators want to highlight the socio-demographic characteristics and describe the spouse abuse, and then related theese factors to " Incapacité Totale de Travail " (term used in law. It is a scale for assessing the importance of injuries).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women consulting for spouse abuse | – | Other: SurveyThe study focuses on women consulting a doctor as part of spouse abuse, whatever the context (at the request of the police or not) or their motivation (medical or social). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women consulting a doctor for intimate partner violence
Key inclusion criteria (5 listed)
- Adult patients
- Admission to emergency for intimate partner violence
- Or consultation to SOS doctor for intimate partner violence
- Or consultation to medico-judicial unit for intimate partner violence
- No verbal opposition to inclusion
Key exclusion criteria (5 listed)
- Non intimate partner violence
- Patient under guardianship or curatorship
- Non French speaker
- Coma or inability to express non-opposition
- Prior participation in another center
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 |
|---|---|---|
| SurveyIt is a survey that the patient and doctor must complete. | Other | Women consulting for spouse abuse |
Primary outcome
Descriptive factors of intimate partner violence on women related to "Incapacité Totale de Travail"
Time frame: Month 24
Highlight the socio-demographic characteristics and the violence suffered by women victims of intimate partner violence, and related this factors to " Incapacité Totale de travail "
2 secondary outcomes
Descriptive factors of intimate partner violence on women related to "Incapacité Totale de travail" for more than eight days.
Time frame: Month 24
Spontaneus request of a medical certificate during the consultation.
Time frame: Month 24
Results and safety
The study was stopped early (reason given: recruitment is insufficient and the current context does not allow satisfactory data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 21193165Leppakoski T, Paavilainen E, Astedt-Kurki P. Experiences of emergency care by the women exposed to acute physical intimate partner violence from the Finnish perspective. Int Emerg Nurs. 2011 Jan;19(1):27-36. doi: 10.1016/j.ienj.2010.02.006. Epub 2010 May 20.
- Background: PubMed 28279677Saberi E, Eather N, Pascoe S, McFadzean ML, Doran F, Hutchinson M. Ready, willing and able? A survey of clinicians' perceptions about domestic violence screening in a regional hospital emergency department. Australas Emerg Nurs J. 2017 May;20(2):82-86. doi: 10.1016/j.aenj.2017.02.001. Epub 2017 Mar 6.
- Background: PubMed 30487886Lopez-Ossorio JJ, Gonzalez Alvarez JL, Buquerin Pascual S, Garcia LF, Buela-Casal G. Risk factors related to intimate partner violence police recidivism in Spain. Int J Clin Health Psychol. 2017 May-Aug;17(2):107-119. doi: 10.1016/j.ijchp.2016.12.001. Epub 2017 Jan 31.
- Background: PubMed 31417842Lyons VH, Kernic MA, Rowhani-Rahbar A, Holt VL, Carone M. Use of multiple failure models in injury epidemiology: a case study of arrest and intimate partner violence recidivism in Seattle, WA. Inj Epidemiol. 2019 Aug 12;6:36. doi: 10.1186/s40621-019-0215-x. eCollection 2019.
- Background: PubMed 31140351Choi AW, Lo BC, Wong JY, Lo RT, Chau PC, Wong JK, Lau CL, Kam CW. Clinical Features of Heterosexual Intimate Partner Violence Victims With Escalating Injury Severity. J Interpers Violence. 2021 Sep;36(17-18):8585-8605. doi: 10.1177/0886260519850539. Epub 2019 May 29.
Related trials for Spouse Abuse
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Study on Violence Against Vulnerable Women and Optimizing Support Services
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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.
Julien PASSERIEUX, Dr principal investigator
CHR d'Orléans
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spouse Abuse, run by Centre Hospitalier Régional d'Orléans at 5 sites in France.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: recruitment is insufficient and the current context does not allow satisfactory data collection). Results are not available in the source record.
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?
Descriptive factors of intimate partner violence on women related to "Incapacité Totale de Travail" (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829474, which also lists 5 linked publications.
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 21 Mar 2022.