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STEPs to Blood Pressure Reduction. (STEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02591394
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Anjail Z Sharrief, 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.

Condition or disease Intervention/treatment Phase
Stroke Prevention Blood Pressure Reduction Behavioral: STEP Clinic Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: STEP Clinic 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.

Active Comparator: Usual Care 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.





Primary Outcome Measures :
  1. Daytime ambulatory systolic blood pressure [ Time Frame: 6 months ]

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591394


Contacts
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Contact: Anjail Z Sharrief, MD MPH 7135006538 anjail.z.sharrief@uth.tmc.edu

Locations
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United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Anjail Z Sharrief, MD MPH    713-500-6538    anjail.z.sharrief@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Georgetown University
Investigators
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Principal Investigator: Anjail Z Sharrief, MD MPH The University of Texas Health Science Center, Houston

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anjail Z Sharrief, Assistant Professor of Neurology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02591394    
Other Study ID Numbers: HSC-MS-15-0416
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases