This study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). Patients are assessed through pre-and post neuropsychological testing.
Patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. Control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration. The primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. Secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. Healthcare utilization variables include annual total cost (current year and prior), number and cost of ER/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. In addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the Six-Minute Walk Test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point. Each subject will participate for a total of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
6 week course of cognitive rehabilitation focused on attention, learning, and memory
an alternative home-based computer program not designed for cognitive remediation but of the same duration
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
RECRUITINGCognitive Functioning
Compare between groups differences in attention (auditory and visual working memory), processing speed (automatic and controlled speed), executive functioning (verbal fluency and mental flexibility), and memory (immediate and delayed verbal and visual modalities) at completion of intervention, 3 months and 6 months using standardized scores.
Time frame: 6 Months
Multiple Sclerosis Self-Efficacy Scale
Measures the person's perspective on maintenance and control over their multiple sclerosis
Time frame: 6 Months
Work Productivity and Activity Impairment Instrument
Measures a person's impairments in their ability to work and participate in chosen activities
Time frame: 6 months
Multiple Sclerosis Quality of Life Inventory
A battery of quality of life scales designed for use by people with MS
Time frame: 6 months
Hospital Anxiety and Depression Scale
Measures depression and anxiety
Time frame: 6 months
Healthcare Utilization
Compare between group differences in annual cost of care, ER visits, hospital visits, hospital length of stay, number of preventive visits, total number of claims, and neurology office visits
Time frame: 12 Months
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