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Completed

NCT Number: NCT00902135

Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion criteria

  • Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
  • Exclusion criteria must be read in conjunction with the German product information.

Treatment and study plan

Interferon beta-1b (Betaseron, BAY86-5046)

Drug

Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder

Primary outcomes

  1. Drop out rate over 2 years

    Time frame: 24 months

Secondary outcomes

  1. Disability status

    Time frame: After 3, 6, 12 and 24 months

  2. Grade of depressiveness

    Time frame: After 3, 6, 12 and 24 months

  3. Grade of fatigue

    Time frame: After 3, 6, 12 and 24 months

  4. Quality of life

    Time frame: After 3, 6, 12 and 24 months

  5. Cognitive status

    Time frame: After 12 and 24 months

  6. Injection regularity

    Time frame: After 3, 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
May 14, 2009
Registry last updated
Jul 17, 2015

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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