Physical Telerehabilitation in Veterans With Multiple Sclerosis
Physical Telerehabilitation in Veterans With Multiple Sclerosis
The primary objective of this study will be to assess the feasibility and patient acceptance of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.
Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation of multiple sclerosis patients. Specifically, the investigators hypothesize that home telemanagement using a daily exercise diary, monitoring of compliance with a tailored exercise program and regular assessment of strength and motor functions will: 1. Be feasible and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality of life
MS is a chronic debilitating disease of the central nervous system which may result in significant damage to the neuromuscular system, vision, and affective and cognitive functions. Approximately 400,000 persons in the United States suffer from MS1, including approximately 28,000 Veterans. The annual cost of MS in the US was estimated at $6.8 billion, and a total estimated lifetime cost per case is $2.2 million. The epidemiology of MS in Veterans has been well described. Most patients with MS develop permanent neurological deficits and enter a progressive phase of the disease after the initial relapsing phase. Recent morbidity studies show that by 15 years from first symptom onset, 20% require a cane to walk. This percentage increases to 69% by 40 years after onset.8 There are four major subtypes of MS: relapsing- remitting (RR), secondary progressive (SP), primary progressive (PP) and progressive relapsing (PrR). The demographics of MS within the US Veteran population are different from those in other population-based cohorts. Firstly, the female to male ratio is 1:2, just the reverse of that seen in other MS cohorts due to the male bias in the military. Second, there is more racial diversity within the Veterans Healthcare Administration (VHA). Third, the mean age of Veterans with MS within VHA is 55 years, 5-10 years older than other comparable North American and European cohorts. Despite these demographic differences, the clinical subtypes of MS are quite comparable as are the use of standard MS medications with other cohorts. The overall neurologic disability of Veterans with MS is slightly more severe compared with other large cohorts.
MS causes functional losses and permanent impairment among a majority of patients. Lifelong rehabilitation measures, together with disease modifying medication treatment, are the major management tools for patients with MS. Physical rehabilitation (PR) is one of the few treatment options together with disease modifying pharmacological therapy for patients with MS which has been shown to be effective in clinical trials. Physical exercises have a positive impact on patient quality of life and their functional capacities. Recent studies have demonstrated that computer technology could be adapted for successful use by patients with MS and other disabling neurological conditions. Modern technology can provide tools to decrease the burden of self-care and enhance patient education and thus lead to more effective MS management. An effective, convenient, generalizable and reliable way to do this would have wide applicability and usefulness. Telerehabilitation has been rapidly developing during the last decade33, and is now in the process of moving from single-case, or small sample research, to controlled trials with larger samples. There is active discussion regarding the cost-effectiveness of telerehabilitation and its financing. For this reason, the proposed study, which evaluates the impact of an MS physical rehabilitation system delivered by telecommunications and computer technology, has the potential of making a significant contribution.
The research plan entails the performance of the following tasks: (1) based on focus group analysis, modify and enhance the HAT System to fully implement the physical therapy component to support multi-level MS physical rehabilitation and patient-provider communication tailored to Veteran-specific needs; (2) conduct a randomized controlled clinical trial to assess the impact of physical telerehabilitation on the patients' clinical and behavioral outcomes, and (3) perform data analysis of the trial and report the results. The HAT system has been implemented using a modular design. Each care component can be dynamically added or its content changed based on a particular care management program requirement without the necessity of software reprogramming. Each care component (such as computer-assisted education module, exercise support and counseling module, symptom diary, etc) is represented by a corresponding relational database structure which allows flexible content update tailored to the specifics of a particular disease management program or population. The MS HAT units will be optimized so patients with MS having motor, sensory, visual and cerebellar deficits can use it efficiently. During the pilot testing we will provide the patient several options for MS HAT enhancements using state-of-the-art technology (e.g. voice- or remote control activated interfaces, cell phone interfaces and keyboard and mouse interfaces) in the operation of the home unit. Patients can choose the best options for this interface and communications with their MS HAT device. A home web-cam option for live interviews with patients, review of exercise plans or clinical follow-ups will be integrated into MS HAT. The specifications of the remote tele-visit component will be finalized based on preferences expressed by Veterans in focus groups. To better understand the preferences and needs of Veterans with MS in terms of the home telerehabilitation program and its features, we will conduct 4 focus groups at the beginning of the study (Months 2-3). The Veteran MS population will allow a more complete evaluation of males, minorities, and individuals of older age compared to the general MS population. The four focus groups will be conducted with participants who have MS disability (Expanded Disability Status Scale or EDSS) scores from 2.0-6.5 according to the randomized controlled trial eligibility criteria. The focus groups will be stratified by gender and disability status. Two groups will be conducted in patients with mild impairment (EDSS=2.0-4.0) and two groups will be conducted in patients with more severe disability (EDSS=4.5-6.5). A secure peer-to-peer social networking component will be integrated within MS HAT. This secure internet-based network will allow text communication between patients with MS in the MS HAT intervention group. All patients in the intervention group will be encouraged to participate in this peer-to-peer component of telerehabilitation support. However, this participation will be optional.
Inclusion Criteria:
Exclusion Criteria: