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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
The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion criteria
Exclusion criteria
- No exclusion criteria for participation in this study were defined.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Germany |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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