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

Multiple Sclerosis Clinical Trial

— PROmyBETAapp  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134573
• Other study ID #: 18462
• Secondary ID: BF1504
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: March 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaferon, BAY86-5046)
Solution for injection

Device:
• Betaconnect auto-injector
Auto-injector for application of Betaferon solution which automatically covers injection related data
• myBETAapp
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

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

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