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

January 23, 2007 updated by: University of Texas Southwestern Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While compliance rates with interferons and glatiramer acetate treatment have been high when assessed in the context of controlled clinical trials, we have observed substantially less consistent rates of drug administration in general practice. Correspondingly, the magnitude of drug efficacy achieved on clinical and surrogate markers of disease activity in the latter patient group may be compromised compared to patients participating in controlled clinical trials. Further, in many circumstances, the perception of breakthrough disease simply constitutes treatment noncompliance.

The National Multiple Sclerosis Society reports only 50% of all MS patients and 60% with relapsing remitting MS are taking disease modifying agents in the U.S. (Zwibel 2003) A number of studies have investigated this challenging issue. When glatiramer acetate therapy was specifically evaluated, the investigators found several factors to be associated with compliance. They discovered adherence to be higher with the patient perception of physician support of the medication prescribed, patient sense of control, higher levels of hope and no previous use of other disease modifying therapy (Fraser, Hadjimichael, and Vollmer 2001). Another study by Hadjimichael and Vollmer (1999) surveyed patients for reasons that medications were discontinued. Disease progression, lack of improvement and side effects were some of the reasons reported by patients for stopping disease-modifying therapy.

Depression is another factor found to impact adherence. Mohr, Goodkin, Likosky, Gatto, Baumann and Rudick (1997) saw increased rates of compliance with Interferon beta-1b therapy in multiple sclerosis with the treatment of underlying depression. The study showed that patients with increased depression were more likely to discontinue therapy. This link of depression has also been demonstrated with noncompliance with antihypertensive medications. (Wang,Bohn, Harooni et al. 2002) In another study, Mohr (2001) saw patient's experienced level of anxiety with their injections was related to adherence.

We hypothesize that a number of factors influence compliance with DMA's, these include:

  1. Patient factors

    1. Perceived quality of life
    2. Empowerment, sense of control & hope
    3. Support structure (family, faith, injection assistance, etc.)
    4. Depression
    5. Fatigue
    6. Cognitive problems
    7. Perception of drug efficacy (benefit over costs)

  2. Physician (HCP support) factors

    1. Patient's perception of MD support
    2. Relationship with MD
    3. Access to nurses and other HCP support functions
    4. Services provided by physician/clinical practice (i.e. academic, community-based, or MS clinic)
    5. Adequate education on MS, establishing reasonable expectations concerning the benefit derived from therapy,

  3. Drug factors

    1. complexity of drug administration
    2. drug associated side effects/tolerability
    3. Perceived MS symptom control
    4. Insurance coverage of the injection
    5. Concomitant medications

Once the factors that contribute to noncompliance to DMA therapies are identified, healthcare professionals can evaluate how they can be impacted. The healthcare team can work towards addressing those barriers where there is a possibility for change, to help improve patient outcomes.

The primary objective of this study is to evaluate the correlation between patient factors, HCP support factors, drug factors, and compliance in patients with relapsing forms of multiple sclerosis (RMS) treated with Disease Modifying Agents (DMA).

The secondary objectives of the study are to determine differences in patient compliance between patients treated by academic centers/MS specialists and community neurology centers; and to determine the factors that impact this difference.

Patients are asked to sign (electronic agreement) a consent to participate in this confidential study when they initially log-on to the study website. Patients are assigned a unique identification number when they log into the internet for the first time to complete the study survey. By using this assigned number, health information will be protected for each individual. Patient names will be used only for purposes of check distribution and participation in following studies if the patient consents. If a patient drops out of the study, TNS Healthcare will contact the patient to find out the reason. The treating physician does not know who elected to participate in the study.

Study Design- This is a multicenter, retrospective trial administered through patient surveys. We are utilizing the validated MS quality of life 54 (MSQOL-54), the Beck's Fast Screen for medical patients, the Hope Herth Index, and a patient self-reported drug compliance survey. The participating neurologists were asked to give patients with relapsing forms of MS flyers describing the study. The flyers direct patients to the designated study website to complete the confidential survey by internet. As described below, patients log-on to the website a total of 3 times during the study period, Baseline (time 0), Month 1 (Time 1) and Month 2 (Time 2). Patients log on with a unique identification number rather than names to ensure that confidentiality is maintained throughout the study.

The goal is to have an equal number of patients treated with the four different DMA's, AVONEX, Rebif, Copaxone, and Betaseron. The sample is to include at least 150-200 patients from each of the MS Centers and 15-20 patients from each of the community sites, for a total of approximately 1040 patients. Power analysis was performed assuming a 15% critical effect value. The sample size was calculated to provide 80% power to detect the critical effect value at a confidence interval of 95%. Response rates are estimated to be 60% for the first wave and 75% for the second wave of questionnaires.

Study Type

Observational

Enrollment

1040

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Biogen

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 25, 2007

Last Update Submitted That Met QC Criteria

January 23, 2007

Last Verified

April 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS DMA Compliance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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