Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

NCT ID: NCT01875328

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Telemedicine

Telemedicine group

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: OTHER

Post stroke follow up in home using telemedicine.

Clinic

Clinic group

Group Type: ACTIVE_COMPARATOR

Clinic

Intervention Type: OTHER

Post stroke clinic group follow up

Interventions

Telemedicine

Post stroke follow up in home using telemedicine.

Intervention Type: OTHER

Clinic

Post stroke clinic group follow up

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darren Larsen, RN

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

9011

Identifier Type: -

Identifier Source: org_study_id