Clinical trial NCT04356339: US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector
Official title: US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: MS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US patients aged ≥18 years diagnosed with Multiple Sclerosis (MS) and treated with BETASERON using the BETACONNECT autoinjector and registered with myBETAapp

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Treated with BETASERON using the BETACONNECT autoinjector
* Registered with myBETAapp
* Provided electronic informed consent

Exclusion Criteria:

- There are no exclusion criteria for participation in this study

Primary outcomes:
measure: Compliance to therapy
timeFrame: Up to 6 months
measure: Persistence of therapy
timeFrame: Up to 6 months
measure: Adherence to therapy
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in patient-reported health-related quality of life (HRQOL)
timeFrame: Up to 6 months
measure: Patient satisfaction with the myBETAapp
timeFrame: Up to 6 months
measure: Change in health status evaluated by EQ-5D-5L descriptive system
timeFrame: Up to 6 months
measure: Change in EQ-Visual Analog Score (EQ-VAS)
timeFrame: Up to 6 months
measure: Change in prescription and non-prescription medication usage
timeFrame: Up to 6 months
measure: Number of relapses
timeFrame: Up to 6 months
measure: Number of participants with treatment with corticosteroids due to relapses
timeFrame: Up to 6 months
measure: Number of emergency room visits due to relapse
timeFrame: Up to 6 months
measure: Number of hospitalizations due to relapse
timeFrame: Up to 6 months
measure: Patient self-assessment
timeFrame: Up to 6 months
measure: Change in dose of BETASERON prescription
timeFrame: Up to 6 months
measure: Change in frequency of BETASERON prescription
timeFrame: Up to 6 months
measure: Patient satisfaction with the BETACONNECT autoinjector
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Whippany
country: United States
facility: myBETAapp
state: New Jersey
Study officials:
References: