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NCT Number: NCT03808142

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

About this study

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

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

  • No exclusion criteria for participation in this study were defined.

Treatment and study plan

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.

PEAK

Other

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

Betaferon, BAY86-5046

Drug

Injection

BETACONNECT

Device

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

Primary outcomes

  1. Compliance percentage to therapy

    Time frame: Up to 12 months from informed consent provided

    Assessed prospectively

  2. Persistence percentage of therapy

    Time frame: Up to 12 months from informed consent provided

    Assessed prospectively

  3. Adherence percentage to therapy, assessed prospectively

    Time frame: Up to 12 months from informed consent provided

    Assessed prospectively

  4. Absolute number of injections missed per 3-month intervals

    Time frame: Up to 12 months from informed consent provided

    Assessed prospectively

  5. Relative proportion of injections missed per 3-month intervals

    Time frame: Up to 12 months from informed consent provided

    Assessed prospectively

Secondary outcomes

  1. Compliance percentage to therapy

    Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

    Assessed retrospectively

  2. Persistence percentage of therapy

    Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

    Assessed retrospectively

  3. Adherence percentage to therapy

    Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

    Assessed retrospectively

  4. Absolute number of injections missed per 3-month intervals

    Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

    Assessed retrospectively

  5. Relative proportion of injections missed per 3-month intervals

    Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

    Assessed retrospectively

  6. Health-related quality of life assessed by questionnaire EQ-5D-5L

    Time frame: Up to 12 months from informed consent provided

    Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Each dimension has 5 levels: (1) no problems , (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems.

  7. Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)

    Time frame: Up to 12 months from informed consent provided

  8. Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)

    Time frame: Up to 12 months from informed consent provided

    This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option "not participating".

  9. Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)

    Time frame: Up to 12 months from informed consent provided

    This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option "not using".

  10. Response level of Satisfaction with the myBETAapp (service questionnaire)

    Time frame: Up to 12 months from informed consent provided

    This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied).

  11. Feedback based on free text on supporting services or devices

    Time frame: Up to 12 months from informed consent provided

    Single question

  12. Number of MS patients using the mobile-based cognitive training tool - PEAK

    Time frame: Up to 12 months from informed consent provided

  13. Proportion of MS patients using the mobile-based cognitive training tool - PEAK

    Time frame: Up to 12 months from informed consent provided

  14. Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)

    Time frame: Up to 12 months from informed consent provided

  15. Duration of mobile-based cognitive training tool - PEAK usage (days)

    Time frame: Up to 12 months from informed consent provided

  16. Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)

    Time frame: Up to 12 months from informed consent provided

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 17, 2019
Registry last updated
Aug 25, 2021

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.

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