Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias. To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.
Study Type
OBSERVATIONAL
Enrollment
498
Patients will be treated with Betaferon
Auto-injector device to support the injection of Betaferon
Unnamed facility
Many Locations, Austria
Unnamed facility
Many Locations, Belgium
Unnamed facility
Many Locations, Bosnia and Herzegovina
Unnamed facility
Many Locations, Croatia
Unnamed facility
Many Locations, Czechia
Unnamed facility
Many Locations, France
Unnamed facility
Many Locations, Greece
Unnamed facility
Many Locations, Hungary
Unnamed facility
Many Locations, Italy
Unnamed facility
Many Locations, Spain
...and 1 more locations
Adherence to therapy at the final visit.
Time frame: Up to 24 weeks
Satisfaction with and evaluation of the BETACONNECT auto-injector
Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection site pain and prophylactic analgesic use
Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Health related quality of life
Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
Time frame: At baseline,12 weeks and 24 weeks
Anxiety
Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
Time frame: At baseline,12 weeks and 24 weeks
Depression
Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
Time frame: At baseline,12 weeks and 24 weeks
Fatigue
Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
Time frame: At baseline,12 weeks and 24 weeks
Cognition
Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
Time frame: At baseline,12 weeks and 24 weeks
Local skin reactions
Local skin reactions will be recorded by HCP evaluation (local inspection).
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
Time frame: At 4 weeks,12 weeks and 24 weeks
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