The objective of the proposed research is to establish the clinical value of a home-based physical telerehabilitation model in veteranswith debilitating nervous system conditions such as multiple sclerosis (MS), and to provide evidence-based recommendations on the use of this technology for care coordination. The primary aim of this study is to determine the effect of home-based physical telerehabilitation on functional outcomes in veterans with MS in a 6 month randomized controlled trial. The primary hypothesis is: Physical telerehabilitation will result in 15% improvement of the Berg Balance Scale Score and a 3-second reduction of timed 25-Foot Walk at 6 months as compared to a control group. Secondary aims of the project include examining the effect of physical telerehabilitation on symptom activity, and behavioral-psychosocial outcomes at 6 months. This study will utilize a permuted block randomization design to compare the effect of home physical telerehabilitation (intervention) with routine rehabilitation care (control) in veterans with MS. Based on a power analysis utilizing data from our pilot study, the required total sample size is 108. A sample of eligible veterans with MS will be recruited within VISN 5 and randomized to the intervention and control groups. Randomization into these groups will also be stratified by two Expanded Disability Status Scale groups (EDSS 2.0-4.0 and EDSS 4.5-6.5). Patients enrolled to the intervention group will receive a Home Automated Telemedicine (HAT) system that will be installed at the patient's home by a research assistant. Both intervention and control groups will receive an individualized physical therapy plan for the 6-month study period and will be trained on how to perform the exercise program. After a baseline evaluation, the patients in the intervention group will receive computer-mediated support in following their individualized exercise plans via HAT at their homes on a daily basis. Study outcome evaluations will be performed at 3 months and 6 months by a blinded clinical team consisting of a physical therapist and a nurse practitioner. The clinical impact of telerehabilitation will be estimated in three major domains: functional status, symptom activity, and the behavioral and psychosocial domain. The primary outcome will be the difference between groups in scores assessing patient functional status by the timed 25-foot walk and the Berg Balance Scale. The functional status will also be assessed using the 6-minute walk, MS Walking Scale, the MS Functional Composite, and the EDSS. Symptom activitywill be a secondary outcome estimated using the Modified Fatigue Impact Scale and the MS Impact Scale. Other secondary outcomes from behavioral and psychosocial domain will include the MS Self-efficacy scale, depression symptoms, and disease-specific quality of life. The results of this study will provide important information on the use of modern telecommunication technologies to improve care in veterans with debilitating chronic neurological disorders. Distance, disability and lack of appropriate specialists often limit access to rehabilitation services within the VA health care system, and the proposed telerehabilitation model provides a way to overcome these barriers. Telerehabilitation could be easily integrated into the VA Care Coordination Home Telehealth initiatives and the myHealtheVet web portal. .

Public Health Relevance

The main purpose of this study is to establish the value of home-based physical telerehabilitation in veterans with debilitating chronic conditions such as multiple sclerosis (MS) and to provide recommendations on the use of this technology for care coordination. The VA has an obligation to provide a consistent level of care to all veterans no matter where they live or how severely they are disabled. The VA has shown its commitment to veterans with MS by funding two MS Centers of Excellence (MSCoE) and recently approving the MS Policy Handbook for care. The PI and co- PI are on staff at the MSCoE-East and this innovative project will provide information on rehabilitation outcomes and ways to improve access and delivery of rehabilitation services.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01RX000293-02
Application #
8499086
Study Section
Aging &Neurodegenerative Disease (RRD6)
Project Start
2012-07-01
Project End
2015-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Baltimore VA Medical Center
Department
Type
DUNS #
City
Baltimore
State
MD
Country
United States
Zip Code
21201