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STEPs to Blood Pressure Reduction. (STEPS)

Primary Purpose

Stroke Prevention, Blood Pressure Reduction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEP Clinic
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STEP Clinic

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Daytime ambulatory systolic blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2015
Last Updated
September 7, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT02591394
Brief Title
STEPs to Blood Pressure Reduction.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding period ended and slow enrollment
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Georgetown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Prevention, Blood Pressure Reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEP Clinic
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
STEP Clinic
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Daytime ambulatory systolic blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Daytime ambulatory diastolic blood pressure
Time Frame
6 months
Title
Nighttime ambulatory systolic blood pressure
Time Frame
6 months
Title
Nighttime ambulatory diastolic c blood pressure
Time Frame
6 months
Title
Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure
Time Frame
6 months
Title
Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure
Time Frame
6 months
Title
Number of participants who are adherent to blood pressure medications
Time Frame
6 months
Title
Depressive Symptoms as assessed by Patient Health Questionnaire 9
Time Frame
6 months
Title
Number of patient monitoring blood pressure at home
Time Frame
6 months
Title
Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form
Time Frame
6 months
Title
Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey
Time Frame
6 months
Title
Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale
Time Frame
6 months
Title
Number of composite cardiovascular events
Description
cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjail Z Sharrief, MD MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30782915
Citation
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.
Results Reference
derived

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STEPs to Blood Pressure Reduction.

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