In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent * taking medication matches the presciber's recommendation (adherence, compliance), * treatment for the prescribed duration (persistence) is continued and * injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.
Study Type
OBSERVATIONAL
Enrollment
100
Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician
myBETAapp
Whippany, New Jersey, United States
Compliance to therapy
Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.
Time frame: Up to 6 months
Persistence of therapy
Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.
Time frame: Up to 6 months
Adherence to therapy
Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.
Time frame: Up to 6 months
Change in patient-reported health-related quality of life (HRQOL)
Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.
Time frame: Up to 6 months
Patient satisfaction with the myBETAapp
Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.
Time frame: Up to 6 months
Change in health status evaluated by EQ-5D-5L descriptive system
EQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Time frame: Up to 6 months
Change in EQ-Visual Analog Score (EQ-VAS)
The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' and provides a single quantitative measure of health.
Time frame: Up to 6 months
Change in prescription and non-prescription medication usage
Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.
Time frame: Up to 6 months
Number of relapses
Time frame: Up to 6 months
Number of participants with treatment with corticosteroids due to relapses
Time frame: Up to 6 months
Number of emergency room visits due to relapse
Time frame: Up to 6 months
Number of hospitalizations due to relapse
Time frame: Up to 6 months
Patient self-assessment
Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.
Time frame: Up to 6 months
Change in dose of BETASERON prescription
Time frame: Up to 6 months
Change in frequency of BETASERON prescription
Time frame: Up to 6 months
Patient satisfaction with the BETACONNECT autoinjector
Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.
Time frame: Up to 6 months
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