STEPs to Blood Pressure Reduction. "STEPS"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Usual care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual Care
  • STEP Clinic Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: STEP Clinic

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Daytime ambulatory systolic blood pressure 6 months No
Secondary Daytime ambulatory diastolic blood pressure 6 months No
Secondary Nighttime ambulatory systolic blood pressure 6 months No
Secondary Nighttime ambulatory diastolic c blood pressure 6 months No
Secondary Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure 6 months No
Secondary Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure 6 months No
Secondary Number of participants who are adherent to blood pressure medications 6 months No
Secondary Depressive Symptoms as assessed by Patient Health Questionnaire 9 6 months No
Secondary Number of patient monitoring blood pressure at home 6 months No
Secondary Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form 6 months No
Secondary Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey 6 months No
Secondary Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale 6 months No
Secondary Number of composite cardiovascular events 6 months No

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