Home-Based Telehealth Stroke Care: A Randomized Trial for Veterans - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00384748

Purpose

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.

Condition	Intervention	Phase
Cerebrovascular Accident	Behavioral: Tele-visit intevention Behavioral: In-home messaging device. Behavioral: Usual care	Phase II

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

physical function as measured by telephone version of FIM [ Time Frame: 9-month ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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) adapative strategies targeting external factors to help compensate for disability. TR will use a combination of 7 televideo visits, an in-home messaging device, and telephone contact over a 6-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aid uses video technology in the patient's home to provide live visual and audio from any location in the home between the patient, home health aid, and 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 televisits, rapid response to new functional problems.	Behavioral: Tele-visit intevention The first 5 tele-visits will occur at 3- and 6-months post-discharge. One additional prn tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to instruct the participant in the exercise component. Visits 3 and 4 focus on functional mobility using adaptive strategy component. Visits 5-7 are directed towards reassessment and progression of the exercise program and adaptive strategies. The equipment used is a wireless tele-video system. It allows real-time observation and interaction and videotape record of each session. The palm size remote videocamera uses wireless radio frequency to transmit real time visual information to a videophone. This videophone is, in turn, connected to the existing telephone line in the home, through which it transmits the image seen through the wireless videocamera's lens to a "base station" videophone located in the hospital. Behavioral: In-home messaging device. The purpose of this aspect of the intervention is to screen for unforseen 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 devcie 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.
2: Active Comparator 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-, 6-, and 9-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.

Arms

Assigned Interventions

1: Experimental

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) adapative strategies targeting external factors to help compensate for disability. TR will use a combination of 7 televideo visits, an in-home messaging device, and telephone contact over a 6-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aid uses video technology in the patient's home to provide live visual and audio from any location in the home between the patient, home health aid, and 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 televisits, rapid response to new functional problems.

Behavioral: Tele-visit intevention

The first 5 tele-visits will occur at 3- and 6-months post-discharge. One additional prn tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to instruct the participant in the exercise component. Visits 3 and 4 focus on functional mobility using adaptive strategy component. Visits 5-7 are directed towards reassessment and progression of the exercise program and adaptive strategies. The equipment used is a wireless tele-video system. It allows real-time observation and interaction and videotape record of each session. The palm size remote videocamera uses wireless radio frequency to transmit real time visual information to a videophone. This videophone is, in turn, connected to the existing telephone line in the home, through which it transmits the image seen through the wireless videocamera's lens to a "base station" videophone located in the hospital.

Behavioral: In-home messaging device.

The purpose of this aspect of the intervention is to screen for unforseen 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 devcie 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.

2: Active Comparator

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-, 6-, and 9-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.

Detailed Description:

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 mobile, wireless video technology with a home health aid in the patient's home to provide live visual and communication from any location in the home between the patient, the home health aid, and 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, 4-site Randomized Controlled Trial (RCT). Subjects will be recruited from 4 VA facilities that differ in the presence of a Rehabilitation Bed Unit (RBU), but are otherwise fairly similar (Tampa, Minneapolis, Durham, and Atlanta VAMCs). The Rehabilitation Outcomes Research Center (RORC) at the Gainesville, FL VAMC 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-, 6-, and 9-months via telephone interviews by the study coordinator located at the RORC who will be blinded to the study group assignment of the patient.

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have acute ischemic or hemorrhagic stroke within the preceding three months, defined as "a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function and persisting longer than 24 hours";
age between 45-90;
discharge to the community;
cognitively intact (score of 6/10 or greater on the Short Portable Mental Status Questionnaire);
discharge motor Functional Independence Measure (FIM) score of 17-88 (i.e., maximal assistance on no more than 4 motor activities of daily living (ADLs) as the most severe stroke included and modified independence at least 2 motor ADLs as the least severe);
an active telephone line in the home;
and informed consent

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384748

Contacts

Contact: Katherine A Carlson

(317) 988-2591

kcarlson@iupui.edu

Locations

United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis	Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Katherine A Carlson 317-988-2591 kcarlson@iupui.edu
Contact: Neale R Chumbler, PhD MA BS (352) 376-1611 ext 4920 Neale.Chumbler@va.gov
Principal Investigator: Neale R. Chumbler, PhD MA BS

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Neale R. Chumbler, PhD MA BS

Richard Roudebush VA Medical Center, Indianapolis

More Information

Responsible Party:	Department of Veterans Affairs ( Chumbler, Neale - Principal Investigator )
Study ID Numbers:	B4492R
Study First Received:	October 3, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00384748
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Cerebrovascular Accident
Rehabilitation
Telemedicine

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009