Phase 2
N=48
Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT00384748 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Physical Function as Measured by Telephone Version of FIM — 83.7; 80.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TR intervention (Behavioral); In-home messaging device. (Behavioral); Usual care (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Function as Measured by Telephone Version of FIM |
83.7; 80.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Have acute ischemic or hemorrhagic stroke within the preceding twenty-four 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); able to follow 3-step command; signed VHA Medical Media release form; concurrence by the patient's physician;
- and informed consent
Exclusion Criteria
Unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT00384748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.