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Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00223457
First received: September 15, 2005
Last updated: January 23, 2007
Last verified: April 2005
History of Changes
  Purpose

The purpose of this study is to evaluate the coorelation between patient factors, health care provider factors, drug factors and compliance in patients with relapsing forms of multiple sclerosis (RMS) treated with Disease Modifying Agents (DMA). We hypothesize that a number of factors influence compliance with DMA's.


Condition Intervention
Multiple Sclerosis
 Behavioral: Factors that influence compliance

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 1040
Study Start Date: April 2004
Estimated Study Completion Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsing form of multiple sclerosis
  • Age 18 or older
  • Therapy with disease modifying agent (Glatiramer acetate, Interferon Beta-1b, ot Interferon Beta 1a (IM or SC) for at least 6 months
  • Access to the internet to complete the study survey

Exclusion Criteria:

  • Diagnosis of progressive forms of multiple sclerosis
  • Therapy on DMA for less than 6 months
  • Inability to complete the survey
  • Participation in other investigational studies within the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223457

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Biogen Idec
Investigators
Principal Investigator: Elliot M Frohman, MD, PhD University of Texas Southwestern Medical Center at Dallas
Principal Investigator: Katherine D Treadaway, LCSW UT Southwestern Medical Center
  More Information

Publications:
Vickery, BG, Hays, RD, Harooni R, Myers, LW, Ellison GW. A health-related quality of life measure of multiple sclerosis. Quality of Life Research: An International Journal of Quality Life Aspects of Treatment, Care and rehabilitation 1995 June 4 (3): 187-206.
1. Zwibel, H. Practical Issues in MS Clinical Management, Patient Choice, Safety, and Adherence. International Journal of MS Care 2003 Oct: (suppl) 18-21.
Hadjimichael O, Vollmer T. Adherence to injection therapy in multiple sclerosis:patients survey. Neurology 1999; 52 (suppl 2):A549

ClinicalTrials.gov Identifier: NCT00223457     History of Changes
Other Study ID Numbers: MS DMA Compliance
Study First Received: September 15, 2005
Last Updated: January 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
multiple sclerosis
compliance
adherence
disease modifying therapy
 depression
hope
quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013