check_circleStudy Completed
Multiple sclerosis
Bayer Identifier:infoA unique number for a trial given by Bayer.
20263
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
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
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.
- 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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
79The overall number of participants needed for a trial.
Trial Dates info
February 2019 - September 2020Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Betaseron (Interferon beta-1b, BAY86-5046)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Germany |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Compliance percentage to therapyAssessed prospectivelydate_rangeTime Frame:Up to 12 months from informed consent provided
- Persistence percentage of therapyAssessed prospectivelydate_rangeTime Frame:Up to 12 months from informed consent provided
- Adherence percentage to therapy, assessed prospectivelyAssessed prospectivelydate_rangeTime Frame:Up to 12 months from informed consent provided
- Absolute number of injections missed per 3-month intervalsAssessed prospectivelydate_rangeTime Frame:Up to 12 months from informed consent provided
- Relative proportion of injections missed per 3-month intervalsAssessed prospectivelydate_rangeTime Frame:Up to 12 months from informed consent provided
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Compliance percentage to therapyAssessed retrospectivelydate_rangeTime Frame:Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Persistence percentage of therapyAssessed retrospectivelydate_rangeTime Frame:Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Adherence percentage to therapyAssessed retrospectivelydate_rangeTime Frame:Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Absolute number of injections missed per 3-month intervalsAssessed retrospectivelydate_rangeTime Frame:Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
- Relative proportion of injections missed per 3-month intervalsAssessed retrospectivelydate_rangeTime Frame: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.date_rangeTime Frame:Up to 12 months from informed consent provided
- Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)date_rangeTime 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”.date_rangeTime 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”.date_rangeTime 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).date_rangeTime Frame:Up to 12 months from informed consent provided
- Feedback based on free text on supporting services or devicesSingle questiondate_rangeTime Frame:Up to 12 months from informed consent provided
- Number of MS patients using the mobile-based cognitive training tool - PEAKdate_rangeTime Frame:Up to 12 months from informed consent provided
- Proportion of MS patients using the mobile-based cognitive training tool - PEAKdate_rangeTime Frame:Up to 12 months from informed consent provided
- Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)date_rangeTime Frame:Up to 12 months from informed consent provided
- Duration of mobile-based cognitive training tool - PEAK usage (days)date_rangeTime Frame:Up to 12 months from informed consent provided
- Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)date_rangeTime Frame:Up to 12 months from informed consent provided
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
OtherAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.