Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials
Study Details
Study Description
Brief Summary
Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The web-based survey is conducted in EU countries where Mayzent (siponimod) is available on the market and reimbursed for at least 6 months, to capture the knowledge and understanding of specific Mayzent safety measures by HCPs and patients/caregivers with access to Mayzent (siponimod).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Health Care Professionals (HCPs) HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod). |
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| Patients/Caregivers Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists across EU markets that will be included in the launch program |
Outcome Measures
Primary Outcome Measures
- Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials. [Throughout study completion, an average of 3 years]
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected
- Knowledge and understanding of the HCPs as per detailed in the educational information provided [Throughout study completion, an average of 3 years]
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 will be measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.
- Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided [Throughout study completion, an average of 3 years]
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 will be measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.
Eligibility Criteria
Criteria
Inclusion Criteria:
Physicians will be considered eligible for the survey if they meet the following screening criteria:
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Care for relapsing MS (RMS) patients
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Personally prescribed disease modifying therapies to MS patients, and;
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Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.
Nurses will be considered eligible for the survey if they:
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Provide supportive care for RMS patients
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Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.
Patient inclusion criteria include:
- Have been initiated onto Mayzent (siponimod) to treat their MS since reimbursement
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Basel | Switzerland |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBAF312A2006