NCT06780540

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 10, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 13, 2025

Last Update Submit

March 5, 2025

Conditions

Enhance Care to Victims of Violence

Keywords

violenceabusepsycho-educationguidelinetrainingpilot studyclinical trialevaluationBelgiumhospitalsvictimshealthcare providersmixed methods researchmulti-method designsexual violencedomestic violenceolder adults

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    An evaluation is completed after testing the psycho-education tool or guideline and takes approximately 10 minutes.

Study Arms (1)

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).

Other: Operation Alert: Support prgram

Interventions

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).

Operation Alert: Support program

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Substudy 1: Psycho-education tool
  • Victims under the age of 16. Substudy 2: Guideline
  • Older adults with cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Aditi ASBL/vzw

Antwerp, 2000, Belgium

RECRUITING

Vertrouwenscentrum Kindermishandeling Antwerpen

Antwerp, 2018, Belgium

RECRUITING

Centre Hospitalier Universitaire Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Vertrouwenscentrum Kindermishandeling Brussel

Brussels, 1000, Belgium

RECRUITING

SOSEnfants Bruxelles ASBL

Brussels, 1200, Belgium

RECRUITING

SOSEnfants Charleroi ASBL

Charleroi, 6000, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

SOSEnfants Namur ASBL

Saint-Servais, 5002, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41516947DERIVED

Related Links

Study Officials

  • Ines Keygnaert, Ph.D

    Ghent University Hospital and Ghent University (VIORESC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Boven, Ph.D

CONTACT

+32494276270charlotte.boven@uzgent.be

Jonathan Harb, MSc

CONTACT

+32456111013jonathan.harb@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

August 24, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

March 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(10)