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

NCT03134573 | Completed

• 2 other identifiers: 18462BF1504
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis (RRMS),; Clinically isolated Syndrome (CIS),; Secondary Progressive Multiple Sclerosis (SPMS)

Outcome Measures

Primary Outcomes (3)

• 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: 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)

  6 months

Secondary Outcomes (2)

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

  3 months

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

  3 months

Study Arms (1)

Multiple Sclerosis

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); Device: Betaconnect auto-injector; Device: myBETAapp

Interventions

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

Solution for injection

Multiple Sclerosis

Betaconnect auto-injector DEVICE

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

Multiple Sclerosis

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

Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.

You may qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

Related Publications (1)

• Limmroth V, Hechenbichler K, Muller C, Schurks M. Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp). J Med Internet Res. 2019 Jul 29;21(7):e14373. doi: 10.2196/14373.

  PMID: 31359863 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Carcinoma in Situ; Multiple Sclerosis, Chronic Progressive

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: September 15, 2017
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)