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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Clinic
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, blood pressure, telemedicine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine

Clinic

Arm Description

Telemedicine group

Clinic group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2013
Last Updated
October 15, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01875328
Brief Title
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Acronym
STEP TO IT
Official Title
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, blood pressure, telemedicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Telemedicine group
Arm Title
Clinic
Arm Type
Active Comparator
Arm Description
Clinic group
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Post stroke follow up in home using telemedicine.
Intervention Type
Other
Intervention Name(s)
Clinic
Intervention Description
Post stroke clinic group follow up
Primary Outcome Measure Information:
Title
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.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Patients being followed in the telemedicine group will achieve rates of goal blood pressure similar to those being followed in clinic.
Time Frame
30 days, 1 year
Other Pre-specified Outcome Measures:
Title
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: History of uncontrolled severe hypertension or refractory to medical management. Severe liver impairment (AST or ALT > 3x normal).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Larsen, RN
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

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