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

June 6, 2013
June 10, 2013
May 2013
June 2015   (final data collection date for primary outcome 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. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01875328 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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 ]
Same as current
 
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stroke
  • Other: Telemedicine
    Post stroke follow up in home using telemedicine.
  • Other: Clinic
    Post stroke clinic group follow up
  • Experimental: Telemedicine
    Telemedicine group
    Intervention: Other: Telemedicine
  • Active Comparator: Clinic
    Clinic group
    Intervention: Other: Clinic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
June 2015   (final data collection date for primary outcome measure)

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).
Both
21 Years and older
No
Contact: Darren Larsen, RN larsedar@ohsu.edu
United States
 
NCT01875328
9011
Yes
Darren Larsen, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Darren Larsen, RN Oregon Health and Science University
Oregon Health and Science University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP