China Betaferon Adherence, Coping and Nurse Support Study

NCT01436838 | Completed

• 2 other identifiers: 15916BF1110CN
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.

Conditions

Multiple Sclerosis, Chronic Progressive

Keywords

Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment

  at 6, 12, 18 and 24 months

Secondary Outcomes (2)

• Ways of Coping Questionnaire (WCQ)

  at 6, 12, 18 and 24 months

• Hospital Anxiety and Depression Scale (HAD)

  at 6, 12, 18 and 24 months

Study Arms (1)

Group 1

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

Interventions

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

All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS center located in general hospital

You may qualify if:

• Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
• Having Betaferon treatment, including patients who are
• First time using; or
• Re-staring; or
• Switching from other diseases modifying drugs (DMDs)

You may not qualify if:

• Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 20, 2011
• Study Start: March 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 5, 2016

Record last verified: 2016-08

Locations

CN (1)