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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaferon, BAY86-5046)
* Device: Betaconnect auto-injector
* Device: myBETAapp


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis<br>Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp | Drug: Interferon beta-1b (Betaferon, BAY86-5046)<br>* Solution for injection<br>Device: Betaconnect auto-injector<br>* Auto-injector for application of Betaferon solution which automatically covers injection related data<br>Device: myBETAapp<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 6 months | 
| Adherence to therapy (yes, no) | Patients will be defined as being adherent to therapy if they fulfill the following criteria: They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing Remitting Multiple Sclerosis (RRMS),, Clinically isolated Syndrome (CIS),, Secondary Progressive Multiple Sclerosis (SPMS)