PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With Betaferon

NCT03808142 | Completed

• 1 other identifier: 20263
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers wanted to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with Betaferon using the myBETAapp which includes the elements to what extent

• taking medication matched the presciber´s recommendation (adherence, compliance),
• treatment for the prescribed duration (persistence) was continued and
• injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study also collected information on the health-related quality of life, treatment satisfaction and satisfaction with treatment support.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• Compliance percentage to therapy

  Assessed prospectively

  Up to 12 months from informed consent provided

• Persistence percentage of therapy

  Assessed prospectively

  Up to 12 months from informed consent provided

• Adherence percentage to therapy, assessed prospectively

  Assessed prospectively

  Up to 12 months from informed consent provided

• Absolute number of injections missed per 3-month intervals

  Assessed prospectively

  Up to 12 months from informed consent provided

• Relative proportion of injections missed per 3-month intervals

  Assessed prospectively

  Up to 12 months from informed consent provided

Secondary Outcomes (16)

• Compliance percentage to therapy

  Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

• Persistence percentage of therapy

  Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

• Adherence percentage to therapy

  Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

• Absolute number of injections missed per 3-month intervals

  Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

• Relative proportion of injections missed per 3-month intervals

  Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

Study Arms (1)

Treatment

During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).

Other: myBETAapp; Other: PEAK; Drug: Betaferon, BAY86-5046; Device: BETACONNECT

Interventions

myBETAapp OTHER

Patients choosing to use the myBETAapp were required to insert the Mixject number from their prescribed Betaferon box, which serves as an opening key for the app. Obtaining a new Betaferon box and obtaining a new Mixject number was not interfere with the process of continuously allocating data to a single patient; each patient had a unique personal identifier in the database. All data recorded in the myBETAapp including demographic and injection-related data were stored in the database once the mobile device was connected to the internet.

Treatment

PEAK OTHER

Peak is an application that aims at helping its users to challenge their brains and keep them sharp.

Treatment

Betaferon, BAY86-5046 DRUG

Injection

Treatment

BETACONNECT DEVICE

BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.

Treatment

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

Women and men in Germany with the diagnosis of MS that were treated with Betaferon and used the myBETAapp were eligible to participate in the study. The option to enroll in the study was offered after log-in procedure to 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 Links

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

MeSH Terms

Conditions

Multiple Sclerosis

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

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 Design

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 17, 2019
• Study Start: February 20, 2019
• Primary Completion: April 20, 2020
• Study Completion: September 2, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

DE (1)