Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study

Bayer96 enrolled

Overview

The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b (Betaferon, BAY86-5046)DRUG

Solution for injection

Betaconnect auto-injectorDEVICE

Auto-injector for application of Betaferon solution which automatically covers injection related data

myBETAappDEVICE

Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥ 18 years. * Patients on treatment with Betaferon (every Betaferon box contains a "Mixject" number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study). * Patients must be using the myBETAapp. * Electronic informed consent must be obtained. Exclusion Criteria: -There are no exclusion criteria for participation in this study.

Locations (1)

Many locations

Multiple Locations, Germany

Outcomes

Primary Outcomes

Compliance to therapy (%)

Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100

Time frame: 6 months

Persistence of therapy (yes, no)

Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)

Time frame: 6 months

Adherence to therapy (yes, no)

Patients will be defined as being adherent to therapy if they fulfill the following criteria: 1. They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and 2. They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)

Time frame: 6 months

Secondary Outcomes

Proportion of patients consenting to participate in this study among those using the myBETAapp

All patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.

Time frame: 3 months

Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp

Wellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habits

Time frame: 3 months

Data from ClinicalTrials.gov

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