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Stroke PreventionSTEPSNCT02591394

STEPs to Blood Pressure Reduction.

A study testing STEP Clinic in people with Stroke Prevention and Blood Pressure Reduction, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke Prevention, Blood Pressure Reduction
What is being tested?
STEP Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteUnited States
Study dates
Nov 2015to 15 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
STEP Clinic, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STEP ClinicBehavioural

    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 CareBehavioural

    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.

Study groups in NCT02591394
Study groupRoleWhat they receive
STEP ClinicExperimentalNot described
Receives: Behavioral: STEP Clinic
Usual CareActive comparatorNot described
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daytime ambulatory systolic blood pressure

    Measured: 6 months

Secondary outcomes (12)

  1. Daytime ambulatory diastolic blood pressure

    Measured: 6 months

  2. Nighttime ambulatory systolic blood pressure

    Measured: 6 months

  3. Nighttime ambulatory diastolic c blood pressure

    Measured: 6 months

  4. Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure

    Measured: 6 months

  5. Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure

    Measured: 6 months

  6. Number of participants who are adherent to blood pressure medications

    Measured: 6 months

  7. Depressive Symptoms as assessed by Patient Health Questionnaire 9

    Measured: 6 months

  8. Number of patient monitoring blood pressure at home

    Measured: 6 months

  9. Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form

    Measured: 6 months

  10. Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey

    Measured: 6 months

  11. Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale

    Measured: 6 months

  12. Number of composite cardiovascular events

    cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion15 Jan 2019
  4. Study completion15 Jan 2019

Why it stopped: Funding period ended and slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02591394
Sponsor's protocol ID
HSC-MS-15-0416
Acronym
STEPS
Status last verified
Sep 2020
First submitted
28 Oct 2015
Last updated
10 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30782915

Questions about this trial

What is this clinical trial studying?

A study testing STEP Clinic in people with Stroke Prevention and Blood Pressure Reduction, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding period ended and slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daytime ambulatory systolic blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02591394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.

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