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STEPs to Blood Pressure Reduction. (STEPS)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Terminated

Conditions

Stroke Prevention
Blood Pressure Reduction

Treatments

Behavioral: STEP Clinic
Behavioral: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02591394
HSC-MS-15-0416

Details and patient eligibility

About

The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic designed for stroke patients and was established to provide a comprehensive approach to stroke risk factor reduction. The goal of this study will be more effective than usual care at reducing blood pressure in patients with poorly controlled blood pressure after an ischemic or hemorrhagic stroke or transient ischemic attack.

Full description

STEP clinic patients will receive personalized goals, instructions to self-monitor, a blood pressure monitor, prescription medications, sleep apnea screening, dietary counseling, and more frequent follow-up if needed. A stroke neurologist will see patients in the usual care group and recommendations will be sent to their primary care providers.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Age ≥ 18
  • Clinical ischemic stroke, intracerebral hemorrhage, or transient ischemic attack
  • Plan to discharge home or to short stay inpatient rehab after stroke
  • Two of following required:
  • History of hypertension (prior to hospitalization)
  • Hospital blood pressure ≥ 140/90 on two or more occasions during hospitalization
  • Discharge home on blood pressure medication
  • Willingness and ability to follow-up in University of Texas Physicians stroke clinic

Exclusion Criteria:

  • Modified Rankin scale (mRs) > 3 at enrollment
  • Terminal illness
  • Chronic kidney disease stage 4 or greater (eGFR < 30)
  • Pregnancy
  • Symptomatic flow limiting carotid stenosis without plan for intervention prior to clinic visit
  • Stroke etiology presumed unrelated to atherosclerotic risk factors (amyloid angiopathy, vasculitis, malignancy associated)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

115 participants in 2 patient groups

STEP Clinic
Experimental group
Treatment:
Behavioral: STEP Clinic
Usual Care
Active Comparator group
Treatment:
Behavioral: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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