Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility (APREVIO)

September 7, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients (stabilized out of crisis or under the influence of substances), men or women over 18 years of age who are able to understand the information letter and the questionnaire and to express their non-opposition. These patients must be under the care of an Addictology structure for addictive behavior, misuse of narcotics or for the consolidation of a sobriety

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Anticipated)

July 14, 2023

Study Completion (Anticipated)

January 14, 2024

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Local/2021 /PP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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