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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Darren Larsen, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01875328
First received: June 6, 2013
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention
Stroke
Other: Telemedicine
Other: Clinic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875328

Contacts
Contact: Darren Larsen, RN larsedar@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Darren Larsen, RN       larsedar@ohsu.edu   
Principal Investigator: Darren Larsen, RN         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Darren Larsen, RN Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Darren Larsen, Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01875328     History of Changes
Other Study ID Numbers: 9011
Study First Received: June 6, 2013
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
stroke
blood pressure
telemedicine

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014