Home-based Telehealth Stroke Care: A Randomized Trial for Veterans

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00384748
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	Phase 2
Start date	November 2008
Completion date	June 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05477238` - Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls	N/A
Completed	`NCT00046293` - ReoPro and Retavase to Treat Acute Stroke	Phase 2
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Completed	`NCT01116544` - Treatment of Chronic Stroke With AMES + EMG Biofeedback	N/A
Withdrawn	`NCT04991038` - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients	N/A
Active, not recruiting	`NCT02563886` - Electrically Assisted Movement Therapy	N/A
Recruiting	`NCT02446730` - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome	Phase 4
Completed	`NCT02141932` - Pocket-size Cardiovascular Ultrasound in Stroke	N/A
Completed	`NCT01915368` - Determining Optimal Post-Stroke Exercise (DOSE)	N/A
Recruiting	`NCT01769326` - Influence of Timing on Motor Learning	N/A
Recruiting	`NCT02557737` - Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities	Phase 3
Terminated	`NCT01705353` - The Role of HMGB-1 in Chronic Stroke	N/A
Completed	`NCT01423201` - Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
Completed	`NCT01656876` - The Effects of Mirror Therapy on Upper Extremity in Stroke Patients	N/A
Completed	`NCT01182818` - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease	N/A
Completed	`NCT00542256` - tDCS and Physical Therapy in Stroke	N/A
Withdrawn	`NCT00573092` - Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs	N/A
Completed	`NCT00377689` - Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke	Phase 2
Recruiting	`NCT00166751` - Sonographic Assessment of Laryngeal Elevation	N/A
Terminated	`NCT00120289` - Niacin Plus Statin to Prevent Vascular Events	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.