RecruitingACTRN12625001257459

From risk to response: recognising and responding to family domestic and sexual violence in Multiple Sclerosis (MS) and broader neurology

From risk to response: recognising and responding to family domestic and sexual violence (FDSV) in Multiple Sclerosis and broader neurology


Sponsor

Monash University

Enrollment

1,044 participants

Start Date

Aug 4, 2025

Study Type

Observational

Conditions

Summary

This study will look at experiences of family, domestic, and sexual violence in people with multiple sclerosis and other neurological conditions. Participants will complete one-time screening, surveys, and optional interviews about their experiences and care, with this information linked to medical records and the MSBase registry. Outcomes of multiple sclerosis will be followed for three years. The study aims to understand how violence affects health and wellbeing, whether it worsens MS through other illnesses and the psychological impact of trauma, and to improve how neurology recognises and responds to violence. Lessons from MS are expected to inform responses across the wider field of neurology.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Multiple sclerosis (MS) and other neurological conditions can increase a person's vulnerability to family, domestic, and sexual violence (FDSV). Yet this intersection is rarely addressed in neurology clinics. This study is working to understand how common FDSV is among people living with MS and neurological conditions, how it affects their health outcomes, and how the healthcare system can better identify and respond to it. Participants with multiple sclerosis will complete screening questionnaires and surveys about their experiences and healthcare, and can optionally take part in an interview. Their MS outcomes will then be tracked over three years. The study will use this information to develop better tools and guidelines for neurologists to recognise and respond to violence in their patients. You may be eligible if you have a diagnosis of multiple sclerosis, are eligible for Medicare, and are able to participate independently. People who are currently in an unsafe situation involving family violence, have unstable mental illness, are under the influence of substances, or are pregnant or breastfeeding are not eligible, to ensure participant safety.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Family, domestic, and sexual violence exposure is assessed once at enrolment through structured screening and once via validated surveys post-enrolment. Retrospective MSBase and clinical data (EDSS, r

Family, domestic, and sexual violence exposure is assessed once at enrolment through structured screening and once via validated surveys post-enrolment. Retrospective MSBase and clinical data (EDSS, relapses, MRI, comorbidities, neuropsychology scores, medications) are collected at enrolment to capture prior disease course. Prospective MS outcomes are then recorded through routine MSBase and clinical follow-up every 3–12 months for 3 years. Qualitative interviews are conducted once per participant. a) Condition/exposure The study observes people with Multiple Sclerosis (MS) and examines exposure to family, domestic, and sexual violence (FDSV). b) Observational data collected Data captured includes MS outcomes (EDSS, relapses, MRI), comorbidities, neuropsychology scores, medications, and prospectively recorded clinical data every 3–12 months. Retrospective data will also be collected from prior outpatient visits documented in the MSBase database. c) Procedures for participants Participants are not required to undertake any additional clinical procedures beyond their usual outpatient neurology visits. The study involves collation of routinely recorded clinical data supplemented by standardised surveys/questionnaires where relevant. d) Frequency and duration of observation Data is collected prospectively at routine visits every 3–12 months over a three-year period. Retrospective data will be extracted from existing medical records in MSBase and outpatient records prior to enrolment. Retrospective data Retrospective data includes MS outcomes (EDSS, relapses, MRI findings), comorbidities, neuropsychology scores, and medication history recorded at prior outpatient neurology visits. This information will be extracted from the MSBase database and site clinical records.


Locations(1)

VIC, Australia

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