STEPs to Blood Pressure Reduction.

Stroke Prevention Clinical Trial

— STEPS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02591394
• Other study ID #: HSC-MS-15-0416
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: January 15, 2019

Study information

• Verified date: September 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure Reduction
• Stroke
• Stroke Prevention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

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