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Completed

NCT Number: NCT04356339

US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector

In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent

* taking medication matches the presciber's recommendation (adherence, compliance), * treatment for the prescribed duration (persistence) is continued and * injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

myBETAapp

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years
  • Treated with BETASERON using the BETACONNECT autoinjector
  • Registered with myBETAapp
  • Provided electronic informed consent

Exclusion criteria

  • There are no exclusion criteria for participation in this study

Treatment and study plan

Interferon-beta-1b (BETASERON, BAY 86-5046)

Drug

Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician

Primary outcomes

  1. Compliance to therapy

    Time frame: Up to 6 months

    Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.

  2. Persistence of therapy

    Time frame: Up to 6 months

    Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.

  3. Adherence to therapy

    Time frame: Up to 6 months

    Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.

Secondary outcomes

  1. Change in patient-reported health-related quality of life (HRQOL)

    Time frame: Up to 6 months

    Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.

  2. Patient satisfaction with the myBETAapp

    Time frame: Up to 6 months

    Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.

  3. Change in health status evaluated by EQ-5D-5L descriptive system

    Time frame: Up to 6 months

    EQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems).

  4. Change in EQ-Visual Analog Score (EQ-VAS)

    Time frame: Up to 6 months

    The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' and provides a single quantitative measure of health.

  5. Change in prescription and non-prescription medication usage

    Time frame: Up to 6 months

    Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.

  6. Number of relapses

    Time frame: Up to 6 months

  7. Number of participants with treatment with corticosteroids due to relapses

    Time frame: Up to 6 months

  8. Number of emergency room visits due to relapse

    Time frame: Up to 6 months

  9. Number of hospitalizations due to relapse

    Time frame: Up to 6 months

  10. Patient self-assessment

    Time frame: Up to 6 months

    Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.

  11. Change in dose of BETASERON prescription

    Time frame: Up to 6 months

  12. Change in frequency of BETASERON prescription

    Time frame: Up to 6 months

  13. Patient satisfaction with the BETACONNECT autoinjector

    Time frame: Up to 6 months

    Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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