Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The primary aim is to determine the effect of TR on physical function, and secondarily to determine the effect on disability, falls-related self-efficacy, and patient satisfaction.
Behavioral: Tele-visit intervention
Behavioral: In-home messaging device.
Behavioral: Usual care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans|
- physical function as measured by telephone version of FIM [ Time Frame: 6-month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
TR intervention consists of two parts that target safe functional mobility of the individual within a home environment: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR will use a combination of 3 tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aide uses the video camera in the patient's home to provide visual and audio to a therapist located at the base hospital. An interactive, in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems (depression, falls, and difficulty with self-care). This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
Behavioral: Tele-visit intervention
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during weeks 2, 4, 6, 8 and 12. One additional tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. Visit 3 focuses on functional mobility using adaptive strategy component.Behavioral: In-home messaging device.
The purpose of this aspect of the intervention is to screen for unforeseen problems and to reinforce adherence to the recommended treatment. It will be used to interface with patients daily, but briefly. The in-home messaging device, which resembles a caller ID box is attached to the home telephone line and electrical outlet. Installation of the equipment involves connecting it to the phone line and plugging it into an electrical outlet. The teletherapist receives the clinical data from the in-home messaging device via the internet on a daily basis. It is used to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence.
Active Comparator: Arm 2
Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.
Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.
Behavioral: Usual care
Routine VA care.
Stroke patients clearly benefit from intensive, coordinated, inpatient care. At the same time, there is considerable interest in ways to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, and lack of sufficient information about the home setting impedes successful rehabilitation. Unfortunately, resources for in-home rehabilitation are limited. The goal of TR is to improve functional mobility using a multifaceted rehabilitation intervention via two types of telehealth technology. Tele-video is used to carry out an in-home assessment of functional mobility, to make treatment recommendations, and to provide periodic goal-oriented reassessment, modifying the treatment plan as the patient improves. Tele-video uses a video camera with a home health aide in the patient's home to provide visual and audio to a therapist located at the base hospital. It is used to carry out an in-home assessment of functional mobility, to make treatment recommendations, and to provide periodic goal-oriented reassessment, modifying the treatment plan as the patient improves. An interactive, in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for interval problems (depression, falls, and difficulty with self-care).
This is a Phase II, 2-arm, 3-site Randomized Controlled Trial (RCT). Subjects will be recruited from 3 VA facilities that differ in the presence of a Rehabilitation Bed Unit (RBU), but are otherwise fairly similar (Tampa, Durham, and Atlanta VAMCs). The Center of Excellence for Implementing Evidence Based Practice (CIEBP) at the Roudebush VAMC in Indianapolis, IN will be the coordinating center. A total of 120 veterans with recent onset of ischemic or hemorrhagic stroke who are discharged to the community will be randomly assigned to one of two groups: (a) TR; and (b) Usual Care. Randomization will be centrally-sealed allocation upon discharge to the community. Dependent variables (physical function, disability, falls-related self-efficacy, and patient satisfaction) will be measured at baseline, 3-, and 6-months via telephone interviews by the study coordinator located at the CIEBP who will be blinded to the study group assignment of the patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384748
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur|
|Decatur, Georgia, United States, 30033|
|United States, Indiana|
|Richard Roudebush VA Medical Center, Indianapolis|
|Indianapolis, Indiana, United States, 46202-2884|
|United States, North Carolina|
|VA Medical Center, Durham|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Neale R. Chumbler, PhD MA BS||Richard Roudebush VA Medical Center, Indianapolis|
|Principal Investigator:||Patricia Ann Quigley, PhD MPH||James A. Haley Veterans Hospital|