Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial (STEP TO IT)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Telemedicine; Other: Clinic

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine; Telemedicine group	Other: Telemedicine; Post stroke follow up in home using telemedicine.
Active Comparator: Clinic; Clinic group	Other: Clinic; Post stroke clinic group follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Darren Larsen, RN, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: stroke; telemedicine; blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 9011