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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439257
• Other study ID #: SDR 94-001
• Status: Completed
• Phase: N/A
• First received: February 21, 2007
• Last updated: April 6, 2015
• Est. completion date: June 2000

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,