China Betaferon Adherence, Coping and Nurse Support Study
Completed
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Interventions
- Registration Number
- NCT01436838
- Lead Sponsor
- Bayer
- Brief Summary
Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
-
Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
-
Having Betaferon treatment, including patients who are
- First time using; or
- Re-staring; or
- Switching from other diseases modifying drugs (DMDs)
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Exclusion Criteria
- Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon beta-1b (Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment at 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method Ways of Coping Questionnaire (WCQ) at 6, 12, 18 and 24 months Hospital Anxiety and Depression Scale (HAD) at 6, 12, 18 and 24 months