NCT02591394

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

October 28, 2015

Last Update Submit

September 7, 2020

Conditions

Stroke PreventionBlood Pressure Reduction

Outcome Measures

Primary Outcomes (1)

  • Daytime ambulatory systolic blood pressure

    6 months

Secondary Outcomes (12)

  • Daytime ambulatory diastolic blood pressure

    6 months

  • Nighttime ambulatory systolic blood pressure

    6 months

  • Nighttime ambulatory diastolic c blood pressure

    6 months

  • Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure

    6 months

  • Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure

    6 months

  • +7 more secondary outcomes

Study Arms (2)

STEP Clinic

EXPERIMENTAL
Behavioral: STEP Clinic

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

STEP ClinicBEHAVIORAL

Patients will visit with STEP clinic staff (including a stroke nurse practitioner or stroke doctor) to receive personalized goals, stroke education (including diet and exercise), instructions to self-monitor using blood pressure cuff, and prescription medications Patient will be scheduled for additional clinic follow-up or be contacted for telephone follow-up for management of your blood pressure. Questionnaires will be administered to determine medication adherence and persistence (following instructions for prescribed medication), disability, depression, cognition, self-efficacy, and sleep apnea. The care plan determined by the STEP clinic will be shared with the patient's primary care provider.

STEP Clinic
Usual CareBEHAVIORAL

Patients will complete questionnaires related to medical history and health behaviors prior to initial visit. After being seen by the stroke neurologist, patients may be scheduled to return to the stroke clinic according the doctor's recommendations. Recommendations for blood pressure and risk factor monitoring will be sent to primary care providers.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Sharrief AZ, Hinojosa E, Cooksey G, Okpala MN, Avritscher EB, Pedroza C, Denny MC, Samuels J, Tyson JE, Savitz SI. Does care in a specialised stroke prevention clinic improve poststroke blood pressure control: a protocol for a randomised comparative effectiveness study. BMJ Open. 2019 Feb 19;9(2):e024695. doi: 10.1136/bmjopen-2018-024695.

    PMID: 30782915DERIVED

Study Officials

  • Anjail Z Sharrief, MD MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

November 1, 2015

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)