check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
18462
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Medication usage and Patient Reported Outcomes evaluation via myBETAapp in patients with multiple sclerosis treated with Betaferon: a pilot study
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
96Trial Dates
September 2017 - May 2018Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Germany |
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))x100date_rangeTime Frame: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)date_rangeTime Frame: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)date_rangeTime Frame: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.date_rangeTime Frame: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 habitsdate_rangeTime Frame:3 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A