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OpenTrials
Completed

NCT Number: NCT01875328

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 21 and over.
  • Diagnosis of ischemic stroke or transient ischemic attack (TIA).
  • mRS≤3 or discharged home or inpatient rehabilitation with the intention to return home with reliable caregiver, regardless of mRS score.
  • Patient is willing and able to comply with all follow up visits for the protocol.
  • Patient available by phone.
  • Patient or caregiver must be able to operate an automated blood pressure cuff.
  • Patients living beyond a 75 mile radius must have private access to a computer to facilitate in-home telemedicine follow up visits.

Exclusion criteria

  • History of uncontrolled severe hypertension or refractory to medical management.
  • Severe liver impairment (AST or ALT > 3x normal).

Treatment and study plan

Telemedicine

Other

Post stroke follow up in home using telemedicine.

Clinic

Other

Post stroke clinic group follow up

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Acronym: STEP TO IT

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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