Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
NCT ID: NCT00384748
Last Updated: 2014-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2008-11-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Usual care
Routine VA care.
Interventions
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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.
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.
Usual care
Routine VA care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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); able to follow 3-step command; signed VHA Medical Media release form; concurrence by the patient's physician;
* and informed consent
Exclusion Criteria
45 Years
90 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Neale R. Chumbler, PhD MA BS
Role: PRINCIPAL_INVESTIGATOR
Richard Roudebush VA Medical Center, Indianapolis
Patricia A Quigley, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
James A. Haley Veterans Hospital
Locations
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Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States
VA Medical Center, Durham
Durham, North Carolina, United States
Countries
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References
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Lutz BJ, Chumbler NR, Lyles T, Hoffman N, Kobb R. Testing a home-telehealth programme for US veterans recovering from stroke and their family caregivers. Disabil Rehabil. 2009;31(5):402-9. doi: 10.1080/09638280802069558.
Chumbler NR, Rose DK, Griffiths P, Quigley P, McGee-Hernandez N, Carlson KA, Vandenberg P, Morey MC, Sanford J, Hoenig H. Study protocol: home-based telehealth stroke care: a randomized trial for veterans. Trials. 2010 Jun 30;11:74. doi: 10.1186/1745-6215-11-74.
Chumbler NR, Morey M, Quigley P, Rose D, Sanford J, Hoenig H. Tele-rehabilitation for Stroke Care: A Randomized Trial for Veterans. [Abstract]. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2010 May 1; 16 Suppl 1:s30.
Chumbler NR, Morey MC, Griffiths P, Quigley P, Haley JA, Rose DK, Sanford J, Hoenig H. The Effects of a Stroke Telerehabilitation In-Home Intervention on Function and Disability: Preliminary Results of a Randomized Clinical Trial. [Abstract]. Stroke; A Journal of Cerebral Circulation. 2011 Mar 1; 42(3):e76.
Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.
Other Identifiers
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B4492-R
Identifier Type: -
Identifier Source: org_study_id