NCT00223457

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,040

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 25, 2007

Status Verified

April 1, 2005

First QC Date

September 15, 2005

Last Update Submit

January 23, 2007

Conditions

Multiple Sclerosis

Keywords

multiple sclerosiscomplianceadherencedisease modifying therapydepressionhopequality of life

Interventions

Factors that influence complianceBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (7)

  • 1. Zwibel, H. Practical Issues in MS Clinical Management, Patient Choice, Safety, and Adherence. International Journal of MS Care 2003 Oct: (suppl) 18-21.

    BACKGROUND

  • Fraser C, Hadjimichael O, Vollmer T. Predictors of adherence to Copaxone therapy in individuals with relapsing-remitting multiple sclerosis. J Neurosci Nurs. 2001 Oct;33(5):231-9. doi: 10.1097/01376517-200110000-00003.

    PMID: 11668881BACKGROUND

  • Hadjimichael O, Vollmer T. Adherence to injection therapy in multiple sclerosis:patients survey. Neurology 1999; 52 (suppl 2):A549

    BACKGROUND

  • Mohr DC, Boudewyn AC, Likosky W, Levine E, Goodkin DE. Injectable medication for the treatment of multiple sclerosis: the influence of self-efficacy expectations and injection anxiety on adherence and ability to self-inject. Ann Behav Med. 2001 Spring;23(2):125-32. doi: 10.1207/S15324796ABM2302_7.

    PMID: 11394554BACKGROUND

  • Mohr DC, Goodkin DE, Likosky W, Gatto N, Baumann KA, Rudick RA. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol. 1997 May;54(5):531-3. doi: 10.1001/archneur.1997.00550170015009.

    PMID: 9152109BACKGROUND

  • Wang PS, Bohn RL, Knight E, Glynn RJ, Mogun H, Avorn J. Noncompliance with antihypertensive medications: the impact of depressive symptoms and psychosocial factors. J Gen Intern Med. 2002 Jul;17(7):504-11. doi: 10.1046/j.1525-1497.2002.00406.x.

    PMID: 12133140BACKGROUND

  • Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

    PMID: 7613530RESULT

MeSH Terms

Conditions

Multiple SclerosisPatient ComplianceDepression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Elliot M Frohman, MD, PhD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • Katherine D Treadaway, LCSW

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

April 1, 2004

Study Completion

September 1, 2005

Last Updated

January 25, 2007

Record last verified: 2005-04

Locations

US(1)