check_circleStudy Completed

Multiple sclerosis

Bayer Identifier:

20263

ClinicalTrials.gov Identifier:

NCT03808142

EudraCT Number:

Not Available

EU CT Number:

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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
79
Trial Dates
February 2019 - September 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • Compliance percentage to therapy
    Assessed prospectively
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Persistence percentage of therapy
    Assessed prospectively
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Adherence percentage to therapy, assessed prospectively
    Assessed prospectively
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Absolute number of injections missed per 3-month intervals
    Assessed prospectively
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Relative proportion of injections missed per 3-month intervals
    Assessed prospectively
    date_rangeTime Frame:
    Up to 12 months from informed consent provided

Secondary Outcome

  • Compliance percentage to therapy
    Assessed retrospectively
    date_rangeTime Frame:
    Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
  • Persistence percentage of therapy
    Assessed retrospectively
    date_rangeTime Frame:
    Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
  • Adherence percentage to therapy
    Assessed retrospectively
    date_rangeTime Frame:
    Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
  • Absolute number of injections missed per 3-month intervals
    Assessed retrospectively
    date_rangeTime Frame:
    Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
  • Relative proportion of injections missed per 3-month intervals
    Assessed retrospectively
    date_rangeTime Frame:
    Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
  • Health-related quality of life assessed by questionnaire EQ-5D-5L
    Five 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 devices
    Single question
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Number of MS patients using the mobile-based cognitive training tool - PEAK
    date_rangeTime Frame:
    Up to 12 months from informed consent provided
  • Proportion of MS patients using the mobile-based cognitive training tool - PEAK
    date_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

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
N/A

Additional Information

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