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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Daytime ambulatory systolic blood pressure
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Arms & Interventions
STEP Clinic
Intervention: STEP Clinic (Behavioral)
Usual Care
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Daytime ambulatory systolic blood pressure
Time Frame: 6 months
Secondary Outcomes
- Daytime ambulatory diastolic blood pressure(6 months)
- Number of patient monitoring blood pressure at home(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)
- Nighttime ambulatory systolic blood pressure(6 months)
- Nighttime ambulatory diastolic c blood pressure(6 months)
- Depressive Symptoms as assessed by Patient Health Questionnaire 9(6 months)
- Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey(6 months)
- Number of participants who are adherent to blood pressure medications(6 months)
- Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form(6 months)
- Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale(6 months)
- Number of composite cardiovascular events(6 months)
Investigators
Anjail Z Sharrief
Assistant Professor of Neurology
The University of Texas Health Science Center, Houston