Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

Stroke Clinical Trial

— STEP TO IT  

Official title:

Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875328
• Other study ID #: 9011
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telemedicine
Post stroke follow up in home using telemedicine.
• Clinic
Post stroke clinic group follow up

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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