Skip to main content
OpenTrials
Completed

NCT Number: NCT03134573

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Carcinoma Carcinoma in Situ Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Solution for injection

Betaconnect auto-injector

Device

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

myBETAapp

Device

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

Primary outcomes

  1. Compliance to therapy (%)

    Time frame: 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

  2. Persistence of therapy (yes, no)

    Time frame: 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)

  3. Adherence to therapy (yes, no)

    Time frame: 6 months

    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)

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PROmyBETAapp

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 1, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.