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.
The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study
Study Type
OBSERVATIONAL
Enrollment
79
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 is an application that aims at helping its users to challenge their brains and keep them sharp.
Injection
BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.
Many locations
Multiple Locations, Germany
Compliance percentage to therapy
Assessed prospectively
Time frame: Up to 12 months from informed consent provided
Persistence percentage of therapy
Assessed prospectively
Time frame: Up to 12 months from informed consent provided
Adherence percentage to therapy, assessed prospectively
Assessed prospectively
Time frame: Up to 12 months from informed consent provided
Absolute number of injections missed per 3-month intervals
Assessed prospectively
Time frame: Up to 12 months from informed consent provided
Relative proportion of injections missed per 3-month intervals
Assessed prospectively
Time frame: Up to 12 months from informed consent provided
Compliance percentage to therapy
Assessed retrospectively
Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Persistence percentage of therapy
Assessed retrospectively
Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Adherence percentage to therapy
Assessed retrospectively
Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Absolute number of injections missed per 3-month intervals
Assessed retrospectively
Time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Relative proportion of injections missed per 3-month intervals
Assessed retrospectively
Time frame: 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.
Time frame: Up to 12 months from informed consent provided
Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)
Time frame: 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".
Time frame: 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".
Time frame: 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).
Time frame: Up to 12 months from informed consent provided
Feedback based on free text on supporting services or devices
Single question
Time frame: Up to 12 months from informed consent provided
Number of MS patients using the mobile-based cognitive training tool - PEAK
Time frame: Up to 12 months from informed consent provided
Proportion of MS patients using the mobile-based cognitive training tool - PEAK
Time frame: Up to 12 months from informed consent provided
Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)
Time frame: Up to 12 months from informed consent provided
Duration of mobile-based cognitive training tool - PEAK usage (days)
Time frame: Up to 12 months from informed consent provided
Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)
Time frame: Up to 12 months from informed consent provided
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