Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384748
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2006-10-03
Brief Title:
Home-based Telehealth Stroke Care A Randomized Trial for Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Home-Based Tele-Health Stroke Care A Randomized Trial for Veterans
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 video camera with a home health aide in the patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None