NCT04930380

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

12 active sites

Status
unknown

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

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

June 3, 2021

Last Update Submit

November 15, 2022

Conditions

Multiple Sclerosis

Keywords

preventive medicine

Outcome Measures

Primary Outcomes (1)

  • questionnaire

    adherence to preventive medicine

    1 year

Study Arms (2)

Cases

* male and female aged 25 years or more * diagnosis of defined MS * written informed consent must be obtained before the enrolment.

Other: phone interview

Controls

* male and female aged 25 years or more * written informed consent must be obtained before the enrolment no history of MS

Other: phone interview

Interventions

phone interviewOTHER

Cases and controls will receive a phone interview

CasesControls

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited in the study among PwMS attending the medium-large sized MS clinical centres, rehabilitation units or among PwMS in contact with the Italian Multiple Sclerosis Association (AISM). In the first two cases the subjects will be enrolled consecutively during ambulatory activities and in the third case the subjects will be randomly selected from the list of AISM's members. Healthcare workers/research assistants, trained for the purpose, will present the project to patients during enrolment. Subjects who give their consent to participate will be contacted by research assistants for a phone interview. Control subjects will be PwoMS volunteers.

You may qualify if:

  • male and female aged 25 years or more
  • written informed consent must be obtained before the enrolment
  • diagnosis of defined MS

You may not qualify if:

  • under the age of 25
  • unable to provide informed consent or to fill in the questionnaire
  • male and female aged 25 years or more
  • written informed consent must be obtained before the enrolment
  • under the age of 25
  • unable to provide informed consent or to fill in the questionnaire
  • history of MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Ferrara

Ferrara, FE, Italy

NOT YET RECRUITING

University of Siena

Sena, SI, 53100, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, TO, Italy

NOT YET RECRUITING

Aulss3- Ospedale dell'Angelo

Mestre, VE, Italy

NOT YET RECRUITING

Università di Cagliari

Cagliari, Italy

NOT YET RECRUITING

Università di Catania

Catania, Italy

NOT YET RECRUITING

Ospedale Murri

Fermo, Italy

NOT YET RECRUITING

Fondazione Italiana Sclerosi Multipla

Genova, Italy

RECRUITING

Università degli Studi di Milano Statale

Milan, Italy

NOT YET RECRUITING

Università degli Studi di Palermo

Palermo, Italy

NOT YET RECRUITING

IRCCS Neuromed

Pozzilli, Italy

NOT YET RECRUITING

Università La Sapienza

Roma, Italy

NOT YET RECRUITING

Related Publications (22)

  • Shaw AR, Feinberg MB. Vaccines. Clinical Immunology. 2008;1353-1382. doi:10.1016/B978-0-323-04404-2.10092-2

    BACKGROUND

  • Hayes JH, Barry MJ. Screening for prostate cancer with the prostate-specific antigen test: a review of current evidence. JAMA. 2014 Mar 19;311(11):1143-9. doi: 10.1001/jama.2014.2085.

    PMID: 24643604BACKGROUND

  • Barrett MW, Roberts B. Preventive Screening in People with Multiple Sclerosis. Int J MS Care. 2010;12:168-176.

    BACKGROUND

  • Dobos K, Healy B, Houtchens M. Access to Preventive Health Care in Severely Disabled Women with Multiple Sclerosis. Int J MS Care. 2015 Jul-Aug;17(4):200-5. doi: 10.7224/1537-2073.2013-046.

    PMID: 26300706BACKGROUND

  • Bisson EJ, Ekuma O, Marrie RA, Leslie WD, Finlayson ML. Factors associated with receiving bone mineral density screening among people with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:305-308. doi: 10.1016/j.msard.2019.01.022. Epub 2019 Jan 8.

    PMID: 30641355BACKGROUND

  • Shabas D, Weinreb H. Preventive healthcare in women with multiple sclerosis. J Womens Health Gend Based Med. 2000 May;9(4):389-95. doi: 10.1089/15246090050020709.

    PMID: 10868611BACKGROUND

  • Beier M, D'Orio V, Spat J, Shuman M, Foley FW. Alcohol and substance use in multiple sclerosis. J Neurol Sci. 2014 Mar 15;338(1-2):122-7. doi: 10.1016/j.jns.2013.12.029. Epub 2013 Dec 27.

    PMID: 24411661BACKGROUND

  • Russell RD, Langer-Gould A, Gonzales EG, Smith JB, Brennan V, Pereira G, Lucas RM, Begley A, Black LJ. Obesity, dieting, and multiple sclerosis. Mult Scler Relat Disord. 2020 Apr;39:101889. doi: 10.1016/j.msard.2019.101889. Epub 2019 Dec 9.

    PMID: 31838309BACKGROUND

  • Diab ME, Johnston MV. Relationships between level of disability and receipt of preventive health services. Arch Phys Med Rehabil. 2004 May;85(5):749-57. doi: 10.1016/j.apmr.2003.06.028.

    PMID: 15129399BACKGROUND

  • Iezzoni LI, McCarthy EP, Davis RB, Siebens H. Mobility impairments and use of screening and preventive services. Am J Public Health. 2000 Jun;90(6):955-61. doi: 10.2105/ajph.90.6.955.

    PMID: 10846515BACKGROUND

  • Farez MF, Correale J, Armstrong MJ, Rae-Grant A, Gloss D, Donley D, Holler-Managan Y, Kachuck NJ, Jeffery D, Beilman M, Gronseth G, Michelson D, Lee E, Cox J, Getchius T, Sejvar J, Narayanaswami P. Practice guideline update summary: Vaccine-preventable infections and immunization in multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2019 Sep 24;93(13):584-594. doi: 10.1212/WNL.0000000000008157. Epub 2019 Aug 28.

    PMID: 31462584BACKGROUND

  • Riva A, Barcella V, Benatti SV, Capobianco M, Capra R, Cinque P, Comi G, Fasolo MM, Franzetti F, Galli M, Gerevini S, Meroni L, Origoni M, Prosperini L, Puoti M, Scarpazza C, Tortorella C, Zaffaroni M, Moiola L. Vaccinations in patients with multiple sclerosis: A Delphi consensus statement. Mult Scler. 2021 Mar;27(3):347-359. doi: 10.1177/1352458520952310. Epub 2020 Sep 17.

    PMID: 32940128BACKGROUND

  • Lebrun C, Vukusic S; French Group for Recommendations in Multiple Sclerosis (France4MS) and the Societe Francophone de la Sclerose En Plaques (SFSEP). Immunization and multiple sclerosis: Recommendations from the French multiple sclerosis society. Mult Scler Relat Disord. 2019 Jun;31:173-188. doi: 10.1016/j.msard.2019.04.004. Epub 2019 Apr 10.

    PMID: 31159998BACKGROUND

  • Melamed E, Lee MW. Multiple Sclerosis and Cancer: The Ying-Yang Effect of Disease Modifying Therapies. Front Immunol. 2020 Jan 10;10:2954. doi: 10.3389/fimmu.2019.02954. eCollection 2019.

    PMID: 31998289BACKGROUND

  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

    PMID: 6685237BACKGROUND

  • Hohol MJ, Orav EJ, Weiner HL. Disease steps in multiple sclerosis: a simple approach to evaluate disease progression. Neurology. 1995 Feb;45(2):251-5. doi: 10.1212/wnl.45.2.251.

    PMID: 7854521BACKGROUND

  • Collins CD, Ivry B, Bowen JD, Cheng EM, Dobson R, Goodin DS, Lechner-Scott J, Kappos L, Galea I. A comparative analysis of Patient-Reported Expanded Disability Status Scale tools. Mult Scler. 2016 Sep;22(10):1349-58. doi: 10.1177/1352458515616205. Epub 2015 Nov 12.

    PMID: 26564998BACKGROUND

  • Katz S, Akpom CA. A measure of primary sociobiological functions. Int J Health Serv. 1976;6(3):493-508. doi: 10.2190/UURL-2RYU-WRYD-EY3K.

    PMID: 133997BACKGROUND

  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

    PMID: 14044222BACKGROUND

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND

  • Naing L, Winn T, Rusli BN. Practical issues in calculating the sample size for prevalence studies. Arch Orofacial Sci 2006;1:9-14.

    BACKGROUND

  • Dupont WD. Power calculations for matched case-control studies. Biometrics. 1988 Dec;44(4):1157-68.

    PMID: 3233252BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Monica Ulivelli, MD

CONTACT

0577.23 3321ulivelli@unisi.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 18, 2021

Study Start

April 1, 2021

Primary Completion

February 28, 2023

Study Completion

March 30, 2023

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(12)