Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439257
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2007-02-21
Brief Title:
Costs Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B Betaseron
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Costs Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B Betaseron
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None