Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
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|ClinicalTrials.gov Identifier: NCT00384748|
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : November 10, 2014
Last Update Posted : November 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Behavioral: TR intervention Behavioral: In-home messaging device. Behavioral: Usual care||Phase 2|
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). 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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2011|
Experimental: Tele-visit Group
TR intervention targets safe functional mobility within a home environment and consists of: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR uses a combination of tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period. A video camera is used in the 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 depression, falls, and difficulty with self-care. This allows evaluations of problem areas during tele-visits, rapid response to new functional problems.
Behavioral: TR 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.
Other Name: Tele-visit intervention
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: Usual Care Group
Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Therapy services are tracked via a weekly diary for the entire 6 month study period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. Usual Care group will be asked whether they exercised, and if so how frequently. They 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.
- Physical Function as Measured by Telephone Version of FIM [ Time Frame: 6-month ]The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 A Quigley, PhD MPH||James A. Haley Veterans Hospital|