Clinical trial NCT01875328: Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Official title: Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
blood pressure
telemedicine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: 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.
timeFrame: up to 1 year
Secondary outcomes:
measure: Patients being followed in the telemedicine group will achieve rates of goal blood pressure similar to those being followed in clinic.
timeFrame: 30 days, 1 year
Other outcomes:
measure: 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.
timeFrame: 1 year
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Darren Larsen, RN
role: PRINCIPAL_INVESTIGATOR
References: