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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaferon, BAY86-5046); Device: Betaconnect auto-injector; Device: myBETAapp

• Registration Number: NCT03134573
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Study Start: 2017-09-15
• Primary Completion: 2018-05-09
• Study Completion: 2018-05-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

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Exclusion Criteria

-There are no exclusion criteria for participation in this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis	Interferon beta-1b (Betaferon, BAY86-5046)	Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp
Multiple Sclerosis	Betaconnect auto-injector	Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp
Multiple Sclerosis	myBETAapp	Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp

Primary Outcome Measures

Name	Time	Method
Compliance to therapy (%)	6 months	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
Persistence of therapy (yes, no)	6 months	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)
Adherence to therapy (yes, no)	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Proportion of patients consenting to participate in this study among those using the myBETAapp	3 months	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.
Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp	3 months	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

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany