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 Details
Study Description
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
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taking medication matched the presciber´s recommendation (adherence, compliance),
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treatment for the prescribed duration (persistence) was continued and
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
Other: PEAK
Peak is an application that aims at helping its users to challenge their brains and keep them sharp.
Drug: Betaferon, BAY86-5046
Injection
Device: BETACONNECT
BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.
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Outcome Measures
Primary Outcome Measures
- Compliance percentage to therapy [Up to 12 months from informed consent provided]
Assessed prospectively
- Persistence percentage of therapy [Up to 12 months from informed consent provided]
Assessed prospectively
- Adherence percentage to therapy, assessed prospectively [Up to 12 months from informed consent provided]
Assessed prospectively
- Absolute number of injections missed per 3-month intervals [Up to 12 months from informed consent provided]
Assessed prospectively
- Relative proportion of injections missed per 3-month intervals [Up to 12 months from informed consent provided]
Assessed prospectively
Secondary Outcome Measures
- Compliance percentage to therapy [Retrospective analysis from 01-Sep-2015 to 15-Apr-2019]
Assessed retrospectively
- Persistence percentage of therapy [Retrospective analysis from 01-Sep-2015 to 15-Apr-2019]
Assessed retrospectively
- Adherence percentage to therapy [Retrospective analysis from 01-Sep-2015 to 15-Apr-2019]
Assessed retrospectively
- Absolute number of injections missed per 3-month intervals [Retrospective analysis from 01-Sep-2015 to 15-Apr-2019]
Assessed retrospectively
- Relative proportion of injections missed per 3-month intervals [Retrospective analysis from 01-Sep-2015 to 15-Apr-2019]
Assessed retrospectively
- Health-related quality of life assessed by questionnaire EQ-5D-5L [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.
- 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) [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".
- Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire) [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".
- Response level of Satisfaction with the myBETAapp (service questionnaire) [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).
- Feedback based on free text on supporting services or devices [Up to 12 months from informed consent provided]
Single question
- 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]
Eligibility Criteria
Criteria
Inclusion criteria
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Patients aged ≥ 18 years.
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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).
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Patients must be using the myBETAapp.
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Electronic informed consent must be obtained.
Exclusion criteria
- No exclusion criteria for participation in this study were defined.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Germany |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20263