Enhance Care to Victims of ViolenceOperatie AlertNCT06780540
Testing and Evaluating a Psychoeducation Tool and Guidelines for Victims of Violence in Belgian Hospitals.
A study testing Operation Alert: Support prgram in people with Enhance Care to Victims of Violence, run by University Hospital, Ghent at 10 sites in Belgium.
Trial summary
The "Operation Alert/Operatie Alert/Opération Alerte" project, developed by UGent-ICRH and UZGent with funding from the Belgian Federal Public Service for Health, focuses on strengthening basic competencies to better and more quickly identify signs of violence. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enhance Care to Victims of Violence
- What is being tested?
- Operation Alert: Support prgram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 10 sitesBelgium
- Study dates
- 24 Aug 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Substudy 1: Psycho-education Tool
- Healthcare Providers: In-hospital healthcare providers who used the psycho-education tool during the pilot phase with a victim of violence.
- Victims/Patients: Victims of violence aged 16 years or older who received psycho-education from an in-hospital healthcare provider during the pilot phase.
- Substudy 2: Guideline
- Healthcare Providers: In-hospital healthcare providers who used the guideline during the pilot phase with an older adult.
- Older Adults/Patients: Older adults with sufficient cognitive abilities who were admitted to the geriatric department (either for a day clinic or a longer stay).
Who cannot join
- Substudy 1: Psycho-education tool
- Victims under the age of 16. Substudy 2: Guideline
- Older adults with cognitive impairments.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Belgium10 sites, 10 recruiting
- Recruiting
Aditi ASBL/vzw
Antwerp, 2000
Miek Scheepers, +32488870677, miek.scheepers@aditivzw.be
- Recruiting
Vertrouwenscentrum Kindermishandeling Antwerpen
Antwerp, 2018
Christina Vandenhove, +3232304190, christina.vandenhove@vkantwerpen.be
- Recruiting
Centre Hospitalier Universitaire Saint-Pierre
Brussels, 1000
Charlotte Rousseau, MD, +3225067075, charlotte.rousseau@stpierre-bru.be
Charlotte Rousseau, MD
- Recruiting
Vertrouwenscentrum Kindermishandeling Brussel
Brussels, 1000
Gerlinde Werdefroy, +3226694050, gerlinde.werdefroy@vkbrussel.be
- Recruiting
SOSEnfants Bruxelles ASBL
Brussels, 1200
Dr. De Becker, +3225353425, sosulb@ulb.ac.be
- Recruiting
SOSEnfants Charleroi ASBL
Charleroi, 6000
Virginie Plennevaux, +3271332581, v.plennevaux@apepcharleroi.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Nele Van Den Noortgate, Ph.D, +3293322916, nele.vandennoortgate@uzgent.be
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Nicolas Berg, MD, +32496719042, berg@docteurberg.be
Nicolas Berg, MD
- Recruiting
AZ Delta
Roeselare, 8800
Lieve Wostyn, MD, +3251236111, lieven.wostyn@azdelta.be
Lieven Wostyn, MD
- Recruiting
SOSEnfants Namur ASBL
Saint-Servais, 5002
Marie-line Feuillat, +3271332581 ext. +3281225415, marie-line.feuillat@sosenfantsnamur.be
About this study
Official title: Testing and Evaluating a Psychoeducational Toolkit and Clinical Screening Guidelines for Victims of Domestic and Sexual Violence in Belgian Hospitals.
The "Operation Alert/Operatie Alert/Opération Alerte" project, developed by UGent-ICRH and UZGent with funding from the Belgian Federal Public Service for Health, focuses on strengthening basic competencies to better and more quickly identify signs of violence. It also aims to provide victim-centered care and refer to specialized services when necessary. This initiative combines training for healthcare providers with practical tools, such as a psycho-education tool and clinical guidelines, to enhance care delivery. Below is an overview of the project's main components:
Sub-Study 1: Psycho-education Tool
Read more
- Objective: Develop and evaluate a tool to support healthcare providers and patients in understanding and addressing sexual and domestic violence, trauma, and their impacts on well-being.
- Tool Description: A set of cards presented in a calendar format, featuring illustrations on one side and explanatory text on the other.
Target Groups: Healthcare providers and victims/patients.
- Development process: The tool was developed based on literature and input from experts and stakeholders during regular meetings.
- Testing Phase: The tool will undergo a pilot study in selected hospitals and non-profit organizations (NGOs) working with victims of violence.
- Evaluation: The tool's acceptability, usability, and relevance to the recovery process will be assessed through feedback collected via questionnaires from both healthcare providers and victims/patients.
Sub-Study 2: Guidelines Older Adults
- Objective: Develop and implement guidelines for screening violence among older adults and providing appropriate care for victims of various forms of violence (psychological, physical, (socio-)economic, and sexual).
- Tool Description: A guideline that includes a screening protocol, care and referral pathways, and theoretical background on the topic.
- Target Group: Older adults with sufficient cognitive abilities.
- Development Process: The guidelines are informed by a literature review, expert, and stakeholder input through regular meetings and focus groups, and a pilot study involving cognitively capable older adults in the geriatric departments of four hospitals.
- Testing Phase: The screening protocol is integrated into standard care procedures, such as intake interviews or geriatric assessments. It is implemented by multidisciplinary professionals, including physicians, nurses, psychologists, occupational therapists, and social workers.
- Evaluation: Feedback on the guidelines is collected from healthcare providers via questionnaires. Older adults themselves are not directly involved in the evaluation, as the screening protocol is intentionally embedded discreetly within standard care procedures.
Training and Support The project includes a robust training component delivered through educational online modules designed to equip healthcare providers with the knowledge and skills necessary to effectively use the tools and guidelines developed.
Languages and Application The study materials and procedures are conducted in both French and Dutch, reflecting Belgium's bilingual context.
Significance This project highlights the importance of tailored support for victims of violence and a systematic approach to care within clinical settings.
- Conditions
- Enhance Care to Victims of Violence
- Being tested
- Operation Alert: Support prgram
- Keywords
- violence, abuse, psycho-education, guideline, training, pilot study, clinical trial, evaluation, Belgium, hospitals, victims, healthcare providers, mixed methods research, multi-method design, sexual violence, domestic violence, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation Alert: Support prgramOther
Substudy 1:
Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ...
Substudy 2:
This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence).
| Study group | Role | What they receive |
|---|---|---|
| Operation Alert: Support program | Experimental | Substudy 1:
Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ...
Substudy 2:
This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence). Receives: Other: Operation Alert: Support prgram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced identification, care, and referral processes for victims of violence.
Conduct a pilot study to evaluate a recently developed psycho-education tool and guideline for healthcare providers (Operation Alert study). These tools aim to enhance the delivery of psycho-education to victims of violence and improve the identification of and care for older victims of violence. The tools are evaluated through a self-developed questionnaire based on the theoretical framework of acceptability by Sekhon (2022), assessing 7 constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy.
In substudy 1, healthcare providers complete 11 open-ended questions and demographics, while patients answer 9 closed questions (Likert 1-5) and 10 open-ended ones. In substudy 2, healthcare providers piloting the guideline have to complete 6 open questions, 11 closed questions (Likert 1-5), and demographics. There are also 11 open-ended questions with no obligation to complete.
Measured: Conducting the psycho-education tool or guideline will not take more than 30 minutes in total.
Secondary outcomes (1)
Evaluating the feasibility and acceptability of the psycho-education tool and guideline in clinical practice.
Targeted adjustments and finalization of the psycho-education tool and guidelines can be made based on the feedback obtained from questionnaires of healthcare providers (substudy 1 and 2) and patients/victims (substudy 1).
The tools are evaluated by using a self-developed questionnaire based on the theoretical framework of acceptability (TFA) by Sekhon (2022). The questions comprise seven component constructs: affective attitude, burden, ethicality intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
The framework presents a generic TFA questionnaire to evaluate the acceptability of interventions from the perspectives of recipients. It can be adapted to assess acceptability of any healthcare intervention. Its development was guided by theory, previous research, and stakeholder input.
Measured: An evaluation is completed after testing the psycho-education tool or guideline and takes approximately 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start24 Aug 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enhance Care to Victims of ViolenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Delta, Centre Hospitalier Universitaire de Liege, Centre Hospitalier Universitaire Saint Pierre, Vertrouwenscentrum Kindermishandeling, Aditi ASBL/vzw, SOS enfants asbl
- Responsible party
- Sponsor
- Investigators
- Ines Keygnaert, Ph.D, Principal investigator, Ghent University Hospital and Ghent University (VIORESC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780540
- Sponsor's protocol ID
- ONZ-2024-0077
- Other IDs
- PSY/JO/Programma IFG-SG-VGV/20
- Acronym
- Operatie Alert
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data are anonymized and encrypted to ensure privacy and security. The research specifically addresses violence, with a focus on sexual and domestic violence among participants aged 16 and older. Sharing any individual patient data would breach the confidentiality of this sensitive group and violate European GDPR regulations.
Publications
Boven C, Nobels A, Berg N, Van Den Noortgate N, Courtens N, Keygnaert I. Screening and Caring for Older Adults Affected by Sexual or Other Types of Violence: A Pilot Study at Three Belgian Geriatric Departments. Healthcare (Basel). 2025 Dec 20;14(1):16. doi: 10.3390/healthcare14010016.
PubMed 41516947
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing and Evaluating a Psychoeducational Toolkit and Clinical Screening Guidelines for Victims of Domestic and Sexual Violence in Belgian Hospitals.
- ClinicalTrials.gov ID
- NCT06780540
- Acronym / sponsor ID
- Operatie Alert / ONZ-2024-0077
- Conditions
- Enhance Care to Victims of Violence
- Keywords
- violence, abuse, psycho-education, guideline, training, pilot study, clinical trial, evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AZ Delta, Centre Hospitalier Universitaire de Liege, Centre Hospitalier Universitaire Saint Pierre, Vertrouwenscentrum Kindermishandeling, Aditi ASBL/vzw, SOS enfants asbl
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Jan 2025 (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.
The "Operation Alert/Operatie Alert/Opération Alerte" project, developed by UGent-ICRH and UZGent with funding from the Belgian Federal Public Service for Health, focuses on strengthening basic competencies to better and more quickly identify signs of violence. It also aims to provide victim-centered care and refer to specialized services when necessary. This initiative combines training for healthcare providers with practical tools, such as a psycho-education tool and clinical guidelines, to enhance care delivery. Below is an overview of the project's main components:
Sub-Study 1: Psycho-education Tool
- Objective: Develop and evaluate a tool to support healthcare providers and patients in understanding and addressing sexual and domestic violence, trauma, and their impacts on well-being.
- Tool Description: A set of cards presented in a calendar format, featuring illustrations on one side and explanatory text on the other.
Target Groups: Healthcare providers and victims/patients.
- Development process: The tool was developed based on literature and input from experts and stakeholders during regular meetings.
- Testing Phase: The tool will undergo a pilot study in selected hospitals and non-profit organizations (NGOs) working with victims of violence.
- Evaluation: The tool's acceptability, usability, and relevance to the recovery process will be assessed through feedback collected via questionnaires from both healthcare providers and victims/patients.
Sub-Study 2: Guidelines Older Adults
- Objective: Develop and implement guidelines for screening violence among older adults and providing appropriate care for victims of various forms of violence (psychological, physical, (socio-)economic, and sexual).
- Tool Description: A guideline that includes a screening protocol, care and referral pathways, and theoretical background on the topic.
- Target Group: Older adults with sufficient cognitive abilities.
- Development Process: The guidelines are informed by a literature review, expert, and stakeholder input through regular meetings and focus groups, and a pilot study involving cognitively capable older adults in the geriatric departments of four hospitals.
- Testing Phase: The screening protocol is integrated into standard care procedures, such as intake interviews or geriatric assessments. It is implemented by multidisciplinary professionals, including physicians, nurses, psychologists, occupational therapists, and social workers.
- Evaluation: Feedback on the guidelines is collected from healthcare providers via questionnaires. Older adults themselves are not directly involved in the evaluation, as the screening protocol is intentionally embedded discreetly within standard care procedures.
Training and Support The project includes a robust training component delivered through educational online modules designed to equip healthcare providers with the knowledge and skills necessary to effectively use the tools and guidelines developed.
Languages and Application The study materials and procedures are conducted in both French and Dutch, reflecting Belgium's bilingual context.
Significance This project highlights the importance of tailored support for victims of violence and a systematic approach to care within clinical settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operation Alert: Support program | Experimental | Other: Operation Alert: Support prgramSubstudy 1: Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ... Substudy 2: This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Substudy 1: Psycho-education Tool
- Healthcare Providers: In-hospital healthcare providers who used the psycho-education tool during the pilot phase with a victim of violence.
- Victims/Patients: Victims of violence aged 16 years or older who received psycho-education from an in-hospital healthcare provider during the pilot phase.
- Substudy 2: Guideline
- Healthcare Providers: In-hospital healthcare providers who used the guideline during the pilot phase with an older adult.
Key exclusion criteria (3 listed)
- Substudy 1: Psycho-education tool
- Victims under the age of 16. Substudy 2: Guideline
- Older adults with cognitive impairments.
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 |
|---|---|---|
| Operation Alert: Support prgramSubstudy 1: Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ... Substudy 2: This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence). | Other | Operation Alert: Support program |
Primary outcome
Enhanced identification, care, and referral processes for victims of violence.
Time frame: Conducting the psycho-education tool or guideline will not take more than 30 minutes in total.
Conduct a pilot study to evaluate a recently developed psycho-education tool and guideline for healthcare providers (Operation Alert study). These tools aim to enhance the delivery of psycho-education to victims of violence and improve the identification of and care for older victims of violence. The tools are evaluated through a self-developed questionnaire based on the theoretical framework of acceptability by Sekhon (2022), assessing 7 constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. In substudy 1, healthcare providers complete 11 open-ended questions and demographics, while patients answer 9 closed questions (Likert 1-5) and 10 open-ended ones. In substudy 2, healthcare providers piloting the guideline have to complete 6 open questions, 11 closed questions (Likert 1-5), and demographics. There are also 11 open-ended questions with no obligation to complete.
1 secondary outcome
Evaluating the feasibility and acceptability of the psycho-education tool and guideline in clinical practice.
Time frame: An evaluation is completed after testing the psycho-education tool or guideline and takes approximately 10 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 41516947Boven C, Nobels A, Berg N, Van Den Noortgate N, Courtens N, Keygnaert I. Screening and Caring for Older Adults Affected by Sexual or Other Types of Violence: A Pilot Study at Three Belgian Geriatric Departments. Healthcare (Basel). 2025 Dec 20;14(1):16. doi: 10.3390/healthcare14010016.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual patient data are anonymized and encrypted to ensure privacy and security. The research specifically addresses violence, with a focus on sexual and domestic violence among participants aged 16 and older. Sharing any individual patient data would breach the confidentiality of this sensitive group and violate European GDPR regulations.
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.
Ines Keygnaert, Ph.D principal investigator
Ghent University Hospital and Ghent University (VIORESC)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation Alert: Support prgram in people with Enhance Care to Victims of Violence, run by University Hospital, Ghent at 10 sites in Belgium.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Boven, Ph.D (+32494276270, charlotte.boven@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced identification, care, and referral processes for victims of violence. (time frame: Conducting the psycho-education tool or guideline will not take more than 30 minutes in total.). 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 NCT06780540, which also lists 1 linked publication.
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 10 Mar 2025.