Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

NCT01875328 | Completed DMC

• 1 other identifier: 9011
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether patients who have had a stroke caused by a blockage of blood flow to the brain can have medical follow up after they leave the hospital in their home using a camera connected to a computer, also called telemedicine. Patients who have follow-up with telemedicine will be compared with patients following up in the usual way, by coming to clinic, and will have the same expectations for medical care and lifestyle changes like quitting smoking, exercising, and controlling their cholesterol. The study will try to show those stroke patients who live 75 miles or more from Oregon Health \& Science University (OHSU) and use a computer for follow up: 1) Will be able to complete the recommended visits using telemedicine in the home as well as those who come to clinic; 2) Will have blood pressures controlled at one year's time as well as those who follow up in the usual way by coming into clinic; 3) The patients followed with telemedicine will be as satisfied with the type of follow up they had as those followed in the usual way in the clinic. In the future, more patients who live at a distance from a major hospital might be able to get quality stroke care follow up using telemedicine if the study finds that telemedicine does meet these goals.

Conditions

Stroke

Keywords

stroke; blood pressure; telemedicine

Outcome Measures

Primary Outcomes (1)

• Outpatient stroke follow-up after discharge using telemedicine in the home is feasible as assessed by visit and intervention adherence for patients living outside a 75 mile radius from OHSU.

  up to 1 year

Secondary Outcomes (1)

• Patients being followed in the telemedicine group will achieve rates of goal blood pressure similar to those being followed in clinic.

  30 days, 1 year

Other Outcomes (1)

• Patients being followed in the telemedicine group will have similar rates of satisfaction with the follow up regimen compared to those in the traditional clinic follow up group.

  1 year

Study Arms (2)

Telemedicine

EXPERIMENTAL

Telemedicine group

Other: Telemedicine

Clinic

ACTIVE COMPARATOR

Clinic group

Other: Clinic

Interventions

Telemedicine OTHER

Post stroke follow up in home using telemedicine.

Telemedicine

Clinic OTHER

Post stroke clinic group follow up

Clinic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 and over.
• Diagnosis of ischemic stroke or transient ischemic attack (TIA).
• mRS≤3 or discharged home or inpatient rehabilitation with the intention to return home with reliable caregiver, regardless of mRS score.
• Patient is willing and able to comply with all follow up visits for the protocol.
• Patient available by phone.
• Patient or caregiver must be able to operate an automated blood pressure cuff.
• Patients living beyond a 75 mile radius must have private access to a computer to facilitate in-home telemedicine follow up visits.

You may not qualify if:

• History of uncontrolled severe hypertension or refractory to medical management.
• Severe liver impairment (AST or ALT \> 3x normal).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Telemedicine; Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Darren Larsen, RN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 11, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2016
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

US (1)