Clinical trial NCT02591394: STEPs to Blood Pressure Reduction.
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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Prevention
Blood Pressure Reduction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2015-10-29
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Daytime ambulatory systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Daytime ambulatory diastolic blood pressure
timeFrame: 6 months
measure: Nighttime ambulatory systolic blood pressure
timeFrame: 6 months
measure: Nighttime ambulatory diastolic c blood pressure
timeFrame: 6 months
measure: Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure
timeFrame: 6 months
measure: Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure
timeFrame: 6 months
measure: Number of participants who are adherent to blood pressure medications
timeFrame: 6 months
measure: Depressive Symptoms as assessed by Patient Health Questionnaire 9
timeFrame: 6 months
measure: Number of patient monitoring blood pressure at home
timeFrame: 6 months
measure: Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form
timeFrame: 6 months
measure: Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey
timeFrame: 6 months
measure: Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale
timeFrame: 6 months
measure: Number of composite cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Anjail Z Sharrief, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.