STEPs to Blood Pressure Reduction.

Not Applicable

Terminated

• Conditions: Blood Pressure Reduction; Stroke Prevention
• Interventions: Behavioral: Usual Care; Behavioral: STEP Clinic

• Registration Number: NCT02591394
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2015-11
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
STEP Clinic	STEP Clinic	-

Primary Outcome Measures

Name	Time	Method
Daytime ambulatory systolic blood pressure	6 months

Secondary Outcome Measures

Name	Time	Method
Daytime ambulatory diastolic blood pressure	6 months
Nighttime ambulatory systolic blood pressure	6 months
Number of patient monitoring blood pressure at home	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
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	cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States