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Description of Adherence to the Main Preventive Health Campaigns of Persons With Multiple Sclerosis

NCT04930380 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1250

Last updated 2022-11-16

No results posted yet for this study

Summary

Persons with multiple sclerosis (PwMS) might be more susceptible to infections and cancers and chronic diseases than general population, not because of the presence of the disease itself, but in relation to some specific therapies use or the degree of disability. Based on the currently available knowledge, the use of many disease-modifying drugs (DMDs) requires special attention to the possibility of infectious events or onset of cancer. In this perspective, a still unmet clinical need in PwMS is the acquisition of a complete picture of the immunization status against the main infectious diseases and the risk of cancer and other chronic diseases. Adherence to preventive pathways can reduce screening time for access to specific treatments, increase safety within complex therapies and reduce the risk of comorbidities.

Despite of the relevance of preventive medicine in clinical decision making, there are no studies in literature on the adherence of these patients to screening and vaccination campaigns in Italy.

The purpose of the study will be to describe the adherence to preventive medicine by PwMS, investigating possible differences between PwMS and people without MS (PwoMS) in the access to vaccinations and screenings. In addition, the investigators will try to identify, in both groups, the potential variables correlated to preventive medicine adherence, including the influence of the Covid(Coronavirus disease)-19 pandemic.

This 1-year project is conceived as a multicenter, observational and retrospective study, divided in two parts. The first one is conceived as a cross-sectional study that will enrol approximately 1250 patients from databases of Clinical Centers, Rehabilitation Units and local branches of the Italian MS Society in Northern, Central and Southern Italy. Patients over 25 years of age with a confirmed diagnosis of MS will be enrolled. Data will be collected through a questionnaire administered by telephone, upon written informed consent.

The second part is designed as a case-control study, that will enrol a subgroup of 300 PwMS (case group) and 300 PwoMS, matched by gender, age and residence area (control group) to analyse the impact of disease and/or disability to access/adherence to preventive medicine.

Knowledge of immunization status and chronic diseases risk is critical for clinical practice in the management of new DMDs but also for public health in determining the possible need for integrated care pathways targeted to PwMS.

Conditions

Interventions

OTHER

phone interview

Cases and controls will receive a phone interview

Sponsors & Collaborators

  • University of Siena

    lead OTHER

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-02-28
Completion
2023-03-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930380 on ClinicalTrials.gov