Costs, Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B (Betaseron)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00439257
First received: February 21, 2007
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the disease process, and progress in understanding the pathogenesis of the inflammatory demyelinating process. The result was to raise new issues in the treatment of the disease, which are then being addressed by studies, including when to initiate treatment and the treatment of partial responders to existing therapies. Paralleling strides in treatment, and of particular importance to the Veterans Administration, was the effectiveness of such therapies, both in terms of cost to the VA Health Care System and quality of life of veterans with multiple sclerosis. This study addressed these issues.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Costs, Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B (Betaseron)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 124
Study Completion Date: June 2000

Detailed Description:

Background:

The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the disease process, and progress in understanding the pathogenesis of the inflammatory demyelinating process. The result was to raise new issues in the treatment of the disease, which are then being addressed by studies, including when to initiate treatment and the treatment of partial responders to existing therapies. Paralleling strides in treatment, and of particular importance to the Veterans Administration, was the effectiveness of such therapies, both in terms of cost to the VA Health Care System and quality of life of veterans with multiple sclerosis. This study addressed these issues.

Objectives:

To consider how then currently used drug therapies for MS in veterans, e.g., Interferon beta-1b, interferon beta-1a and glatiramer acetate impact health related quality of life (HRQoL), physical function and disability and use of health care resources within the VA. Comparisons with other groups of veterans with specific chronic medical conditions will be made in order to develop a model of health care utilization based on indices derived from disability and impairment evaluations and HRQoL instruments.

Methods:

One hundred and twenty four veterans with a clinically definite multiple sclerosis at more than 30 VAMCs participated in this observational, prospective study. Prior to starting interferon beta-1b [IFNB-1b: Betaseron (tm)], interferon beta-1a [IFNB-1a: Avonex (tm)] or glatiramer acetate [Copaxone (tm)] baseline assessments were obtained: disability and impairment using the Kurtzke Expanded Disability Status Scale (EDSS) and Functional Scales (FS), and health related quality of life (HRQoL) using a veterans-modified version of the Short Quality of Life scale (SF-36V). Follow-up evaluations were performed at three months and every six months thereafter for three years. Veterans were monitored in terms of changes in their condition, side effects from drugs, and changes in therapies. Health utilization data obtained includes clinic stops, inpatient hospitalizations, cost of medications and supplies, training, referrals for prosthetics, rehabilitative therapies and long term care.

Status:

Completed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veteran enrolled at participating hospitals who have MS and are receiving the drugs of interest.

Exclusion Criteria:

Non-veterans or veterans not meeting the inclusion criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439257

Locations
United States, Connecticut
VA Connecticut Health Care System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph B. Guarnaccia, MD VA Connecticut Health Care System
Principal Investigator: Robert M. Baumhefner, MD VA Greater Los Angeles Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00439257     History of Changes
Other Study ID Numbers: SDR 94-001
Study First Received: February 21, 2007
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

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
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 22, 2014