Clinical trial 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
Official title: PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance percentage to therapy
timeFrame: Up to 12 months from informed consent provided
measure: Persistence percentage of therapy
timeFrame: Up to 12 months from informed consent provided
measure: Adherence percentage to therapy, assessed prospectively
timeFrame: Up to 12 months from informed consent provided
measure: Absolute number of injections missed per 3-month intervals
timeFrame: Up to 12 months from informed consent provided
measure: Relative proportion of injections missed per 3-month intervals
timeFrame: Up to 12 months from informed consent provided
Secondary outcomes:
measure: Compliance percentage to therapy
timeFrame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
measure: Persistence percentage of therapy
timeFrame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
measure: Adherence percentage to therapy
timeFrame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
measure: Absolute number of injections missed per 3-month intervals
timeFrame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
measure: Relative proportion of injections missed per 3-month intervals
timeFrame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
measure: Health-related quality of life assessed by questionnaire EQ-5D-5L
timeFrame: Up to 12 months from informed consent provided
measure: Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)
timeFrame: Up to 12 months from informed consent provided
measure: Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)
timeFrame: Up to 12 months from informed consent provided
measure: Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)
timeFrame: Up to 12 months from informed consent provided
measure: Response level of Satisfaction with the myBETAapp (service questionnaire)
timeFrame: Up to 12 months from informed consent provided
measure: Feedback based on free text on supporting services or devices
timeFrame: Up to 12 months from informed consent provided
measure: Number of MS patients using the mobile-based cognitive training tool - PEAK
timeFrame: Up to 12 months from informed consent provided
measure: Proportion of MS patients using the mobile-based cognitive training tool - PEAK
timeFrame: Up to 12 months from informed consent provided
measure: Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)
timeFrame: Up to 12 months from informed consent provided
measure: Duration of mobile-based cognitive training tool - PEAK usage (days)
timeFrame: Up to 12 months from informed consent provided
measure: Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)
timeFrame: Up to 12 months from informed consent provided
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: