Trial Condition(s):
Multiple Sclerosis
Medication usage and Patient Reported Outcomes evaluation via myBETAapp in patients with multiple sclerosis treated with Betaferon: a pilot study (PROmyBETAapp)
Bayer Identifier:
18462
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.
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
-There are no exclusion criteria for participation in this study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
PROmyBETAapp: Ascertaining medication usage & documentation of Patient Reported Outcomes utilizing the myBETAapp® in patients with multiple sclerosis treated with Betaferon®: a pilot study
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Compliance to therapy (%)Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100Timeframe: 6 months
- Persistence of therapy (yes, no)Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)Timeframe: 6 months
- Adherence to therapy (yes, no)Patients will be defined as being adherent to therapy if they fulfill the following criteria: a) They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and b)They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)Timeframe: 6 months
Secondary Outcome
- Proportion of patients consenting to participate in this study among those using the myBETAappAll patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.Timeframe: 3 months
- Proportion of patients volunteering to record wellness related data in each of the following categories on the “Wellness chart” on the myBETAappWellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habitsTimeframe: 3 months
Additional Information
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