STEPs to Blood Pressure Reduction. (STEPS)

STEPs to Blood Pressure Reduction. A Randomized Clinical Trial of the Stroke Transitions, Education, and Prevention Clinic Versus Usual Care for Post-Stroke Blood Pressure Reduction

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.

Study Overview

• Status: Terminated
• Conditions: Stroke Prevention; Blood Pressure Reduction
• Intervention / Treatment: Behavioral: STEP Clinic; Behavioral: Usual Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; 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.
Experimental: STEP Clinic	Behavioral: STEP Clinic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daytime ambulatory systolic blood pressure	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of participants who are adherent to blood pressure medications		6 months
Depressive Symptoms as assessed by Patient Health Questionnaire 9		6 months
Number of patient monitoring blood pressure at home		6 months
Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form		6 months
Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey		6 months
Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale		6 months
Number of composite cardiovascular events	cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke	6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Georgetown University
• Investigators: Principal Investigator: Anjail Z Sharrief, MD MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-MS-15-0416