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

Study Overview
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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

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: myBETAapp
* Other: PEAK
* Drug: Betaferon, BAY86-5046
* Device: BETACONNECT


Participation Criteria
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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. Exclusion criteria - No exclusion criteria for participation in this study were defined.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>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<br>* 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.<br>Other: PEAK<br>* Peak is an application that aims at helping its users to challenge their brains and keep them sharp.<br>Drug: Betaferon, BAY86-5046<br>* Injection<br>Device: BETACONNECT<br>* BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance percentage to therapy | Assessed retrospectively | Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 | 
| Persistence percentage of therapy | Assessed retrospectively | Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 | 
| Adherence percentage to therapy | Assessed retrospectively | Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 | 
| Absolute number of injections missed per 3-month intervals | Assessed retrospectively | Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 | 
| Relative proportion of injections missed per 3-month intervals | Assessed retrospectively | Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 | 
| Health-related quality of life assessed by questionnaire EQ-5D-5L | 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. | Up to 12 months from informed consent provided | 
| Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II) |  | Up to 12 months from informed consent provided | 
| Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire) | 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. | Up to 12 months from informed consent provided | 
| Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire) | 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. | Up to 12 months from informed consent provided | 
| Response level of Satisfaction with the myBETAapp (service questionnaire) | This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied). | Up to 12 months from informed consent provided | 
| Feedback based on free text on supporting services or devices | Single question | Up to 12 months from informed consent provided | 
| Number of MS patients using the mobile-based cognitive training tool - PEAK |  | Up to 12 months from informed consent provided | 
| Proportion of MS patients using the mobile-based cognitive training tool - PEAK |  | Up to 12 months from informed consent provided | 
| Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week) |  | Up to 12 months from informed consent provided | 
| Duration of mobile-based cognitive training tool - PEAK usage (days) |  | Up to 12 months from informed consent provided | 
| Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes) |  | Up to 12 months from informed consent provided |