- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05536245
Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility (APREVIO)
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence.
Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions.
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Study Overview
Detailed Description
Study visits will be conducted in the following chronological order:
i. Inclusion/End Visit (IEV): D0.Eligible patients will have been identified by the investigator, and will be recruited in the Addictology Department during their usual visit.
The inclusion visit is carried out by an investigating physician who will confirm the patient's eligibility and verify his or her ability to answer the questionnaire. It will take place in the care center. It is part of the usual care.
During this visit, the investigator will:
- Perform the usual management of the patient.
- Validate the inclusion and non-inclusion criteria.
- Issue the letter of information and non-opposition
ii. Self-questionnaire entry visit (Vfollow-up/end): from D0 to 18 months (part of the usual care). After inclusion, the subject has enough time (15-30 min) to fill in the questionnaire independently. If the subject asks for it, the doctor can give him an explanation or clarify the meaning of a question and let him answer it alone. After completing the questionnaire, the subject will have no further obligations in relation to the study.The patient will complete an electronic self-questionnaire independently.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pascal PERNEY, MD, PhD
- Phone Number: 04.66.68.42.75
- Email: pascal.perney@chu-nimes.fr
Study Locations
-
-
-
Béziers, France, 34525
- Not yet recruiting
- Gaëlle SULTAN-TIHLL
-
Contact:
- Gaëlle SULTAN-TIHLL, MD
- Phone Number: 04.67.35.76.32
- Email: Gaelle.sultan-thill@ch-béziers.fr
-
Montpellier, France, 34295
- Not yet recruiting
- Hélène DONNADIEU
-
Contact:
- Hélène DONNADIEU, MD
- Phone Number: 04.67.33.70.21
- Email: h-donnadieu_rigole@chu-montpellier.fr
-
Nîmes, France, 30029
- Recruiting
- Pascal PERNEY
-
Contact:
- Pascal PERNEY, MD, PhD
- Phone Number: 04.66.68.42.75
- Email: pascal.perney@chu-nimes.fr
-
Contact:
- Anne Clarisse SIMONET, PhD
- Phone Number: 04 66 68 51 40
- Email: anne.clarisse.simonet@chu-nimes.fr
-
Toulouse, France, 31059
- Not yet recruiting
- Nicolas FRANCHITTO
-
Contact:
- Nicolas FRANCHITTO, MD PhD
- Phone Number: 05.67.69.16.42
- Email: franchitto.n@chu-toulouse.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Outpatient under care in an Addictology structure.
- Male or female patient over 18 years old.
- Outpatient able to express his/her non-opposition.
Exclusion Criteria:
Patient consulting for the first time. Patient under court protection, guardianship or curatorship. Severe psychiatric disorders that have not been stabilized: (schizophrenia, bipolar disorders, etc.).
Severe neurological disorders that are incompatible with reliable data collection.
Minor patients. Pregnant women, parturients. People in emergency situations, people unable to express their consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of violence among patients suffering from one or more addictions and treated in an Addictology Center.
Time Frame: Between Day1 and 18 Months
|
Frequency of each type of violent act.
|
Between Day1 and 18 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relation between addiction habits and violence
Time Frame: Between Day 1 and 18 Months
|
Number of positive responses
|
Between Day 1 and 18 Months
|
Percentage of positive respons in terms of frequency of violence and need for specific help.and the acceptability of specific help by patients
Time Frame: Between Day 1 and 18 Months
|
Number of positive responses
|
Between Day 1 and 18 Months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local/2021 /PP-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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