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

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT01875328
Collaborator
(none)
64
1
2
46
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telemedicine
  • Other: Clinic
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Actual Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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 Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health and Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01875328
Other Study ID Numbers:
  • 9011
First Posted:
Jun 11, 2013
Last Update Posted:
Oct 17, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Oregon Health and Science University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2019