Trial Condition(s):
Multiple Sclerosis
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
Bayer Identifier:
20263
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
PROmyBETAappGame: Ascertaining medication usage & Patient Reported Outcomes via the myBETAapp and exploring gamification in patients with multiple sclerosis treated with Betaferon
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Compliance percentage to therapyAssessed prospectivelyTimeframe: Up to 12 months from informed consent provided
- Persistence percentage of therapyAssessed prospectivelyTimeframe: Up to 12 months from informed consent provided
- Adherence percentage to therapy, assessed prospectivelyAssessed prospectivelyTimeframe: Up to 12 months from informed consent provided
- Absolute number of injections missed per 3-month intervalsAssessed prospectivelyTimeframe: Up to 12 months from informed consent provided
- Relative proportion of injections missed per 3-month intervalsAssessed prospectivelyTimeframe: Up to 12 months from informed consent provided
Secondary Outcome
- Compliance percentage to therapyAssessed retrospectivelyTimeframe: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Persistence percentage of therapyAssessed retrospectivelyTimeframe: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Adherence percentage to therapyAssessed retrospectivelyTimeframe: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Absolute number of injections missed per 3-month intervalsAssessed retrospectivelyTimeframe: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Relative proportion of injections missed per 3-month intervalsAssessed retrospectivelyTimeframe: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Health-related quality of life assessed by questionnaire EQ-5D-5LFive 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.Timeframe: Up to 12 months from informed consent provided
- Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)Timeframe: 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”.Timeframe: 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”.Timeframe: 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).Timeframe: Up to 12 months from informed consent provided
- Feedback based on free text on supporting services or devicesSingle questionTimeframe: Up to 12 months from informed consent provided
- Number of MS patients using the mobile-based cognitive training tool - PEAKTimeframe: Up to 12 months from informed consent provided
- Proportion of MS patients using the mobile-based cognitive training tool - PEAKTimeframe: Up to 12 months from informed consent provided
- Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)Timeframe: Up to 12 months from informed consent provided
- Duration of mobile-based cognitive training tool - PEAK usage (days)Timeframe: Up to 12 months from informed consent provided
- Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)Timeframe: Up to 12 months from informed consent provided
Additional Information
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