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

NCT ID: NCT03808142

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-20

Study Completion Date

2020-09-02

Brief Summary

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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.

Detailed Description

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The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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).

myBETAapp

Intervention Type 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.

PEAK

Intervention Type OTHER

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

Betaferon, BAY86-5046

Intervention Type DRUG

Injection

BETACONNECT

Intervention Type DEVICE

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

Interventions

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myBETAapp

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.

Intervention Type OTHER

PEAK

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

Intervention Type OTHER

Betaferon, BAY86-5046

Injection

Intervention Type DRUG

BETACONNECT

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/

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Other Identifiers

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20263

Identifier Type: -

Identifier Source: org_study_id

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