Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials

N/ACompletedNCT05301907

Novartis Pharmaceuticals335 enrolled

Overview

Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

The survey- based study was conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

Study Type

OBSERVATIONAL

Enrollment

335

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: Physicians were considered eligible for the survey if they meet the following screening criteria: * Care for relapsing MS (RMS) patients * Personally prescribed disease modifying therapies to MS patients, and; * Have prescribed Mayzent (siponimod) in at least 1 SPMS patient. Nurses were considered eligible for the survey if they: * Provide supportive care for RMS patients * Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient. Patient inclusion criteria include: \- Had initiated onto Mayzent (siponimod) to treat their MS since reimbursement Exclusion Criteria: \-

Locations (1)

Novartis Investigative Site

Basel, Switzerland

Outcomes

Primary Outcomes

Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.

Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected

Time frame: Throughout study completion, an average of 3 years

Knowledge and understanding of the HCPs as per detailed in the educational information provided

Knowledge and understanding of the HCPs as per detailed in the educational information provided relating to: * The appropriate initiation * Specific safety measures when treating patients with Mayzent (siponimod) * Steps when treating patients with sinus bradycardia, 1st/2nd degree AV block or history of myocardial infarction or health failure * Procedures for the management of infections, macular edema, skin malignancies and pregnancy considerations. * Steps in ophthalmology checklist, managing infection risk, pregnancy, liver function and skin examinations Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

Time frame: Throughout study completion, an average of 3 years

Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided

Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided relating to: * Specific safety measures when being treated with Mayzent (siponimod) * Side effects and potential risks Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

Time frame: Throughout study completion, an average of 3 years

Data from ClinicalTrials.gov

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