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

NCT ID: NCT00902135

Last Updated: 2015-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

702 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

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

Group 2

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

Intervention Type DRUG

Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder

Group 3

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

Intervention Type DRUG

Interferon beta-1b (Betaferon)

Interventions

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

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

Intervention Type DRUG

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

Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder

Intervention Type DRUG

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

Interferon beta-1b (Betaferon)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Germany

Site Status

Countries

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Germany

References

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Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Hecker M; Study Group. Comparative evaluation of patients' and physicians' satisfaction with interferon beta-1b therapy. BMC Neurol. 2016 Sep 21;16(1):181. doi: 10.1186/s12883-016-0705-1.

Reference Type DERIVED
PMID: 27653529 (View on PubMed)

Zettl UK, Bauer-Steinhusen U, Glaser T, Czekalla J, Hechenbichler K, Limmroth V, Hecker M. Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary. Adv Ther. 2016 May;33(5):834-47. doi: 10.1007/s12325-016-0325-6. Epub 2016 Apr 18.

Reference Type DERIVED
PMID: 27090116 (View on PubMed)

Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V; Study Group. Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study. BMC Neurol. 2013 Sep 6;13:117. doi: 10.1186/1471-2377-13-117.

Reference Type DERIVED
PMID: 24011220 (View on PubMed)

Other Identifiers

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BF0801DE

Identifier Type: OTHER

Identifier Source: secondary_id

14543

Identifier Type: -

Identifier Source: org_study_id

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