STEPs to Blood Pressure Reduction. (STEPS)

• ClinicalTrials.gov Identifier: NCT02591394
• Recruitment Status: Terminated
• First Posted: October 29, 2015
• Last Update Posted: September 10, 2020
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Georgetown University
• Information provided by (Responsible Party): Anjail Z Sharrief, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: October 28, 2015
• First Posted Date: October 29, 2015
• Last Update Posted Date: September 10, 2020
• Study Start Date: November 2015
• Actual Primary Completion Date: January 15, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 28, 2015): Daytime ambulatory systolic blood pressure [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 28, 2015)

• Daytime ambulatory diastolic blood pressure [ Time Frame: 6 months ]
• Nighttime ambulatory systolic blood pressure [ Time Frame: 6 months ]
• Nighttime ambulatory diastolic c blood pressure [ Time Frame: 6 months ]
• Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure [ Time Frame: 6 months ]
• Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure [ Time Frame: 6 months ]
• Number of participants who are adherent to blood pressure medications [ Time Frame: 6 months ]
• Depressive Symptoms as assessed by Patient Health Questionnaire 9 [ Time Frame: 6 months ]
• Number of patient monitoring blood pressure at home [ Time Frame: 6 months ]
• Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form [ Time Frame: 6 months ]
• Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey [ Time Frame: 6 months ]
• Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale [ Time Frame: 6 months ]
• Number of composite cardiovascular events [ Time Frame: 6 months ]
  cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: STEPs to Blood Pressure Reduction.
• Official Title: 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
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Stroke Prevention
• Blood Pressure Reduction

Intervention

• 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.
• 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.

Study Arms

• Experimental: STEP Clinic
  Intervention: Behavioral: STEP Clinic
• Active Comparator: Usual Care
  Intervention: Behavioral: Usual Care

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 7, 2020): 115
• Original Estimated Enrollment (submitted: October 28, 2015): 200
• Actual Study Completion Date: January 15, 2019
• Actual Primary Completion Date: January 15, 2019 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02591394
• Other Study ID Numbers: HSC-MS-15-0416
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anjail Z Sharrief, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Georgetown University

Investigators

• Principal Investigator: Anjail Z Sharrief, MD MPH; The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: September 2020