STEPs to Blood Pressure Reduction.

NCT ID: NCT02591394

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-01-15

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.

Conditions

Stroke Prevention; Blood Pressure Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

STEP Clinic

Group Type: EXPERIMENTAL

STEP Clinic

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Anjail Z Sharrief

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anjail Z Sharrief, MD MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30782915 (View on PubMed)

Other Identifiers

HSC-MS-15-0416

Identifier Type: -

Identifier Source: org_study_id