Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor

NCT05730465 | Recruiting

• 1 other identifier: 68463
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients. The main question\[s\] it aims to answer are:

• Take their blood pressure at home and records the results
• Participate in follow-up phone calls from investigators at at 3 and 6 months Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education

Conditions

Hypertension; Stroke; TIA; Vascular Diseases

Keywords

Hypertension; Stroke; TIA; Home blood pressure monitoring

Outcome Measures

Primary Outcomes (2)

• Blood pressure

  Home blood pressure measurements provided by patient at month 3

  Month 3

• Blood pressure

  Home blood pressure measurements provided by patient at month 6

  Month 6

Secondary Outcomes (3)

• Incidence of stroke

  Months 3 and 6

• Incidence of TIA

  Months 3 and 6

• Any hospitalization

  Months 3 and 6

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants will receive routine stroke discharge education which is standard of care. A stroke nurse will provide and review with the patient a short informational pamphlet on the importance of blood pressure monitoring.

Access to Blood Pressure Monitoring

EXPERIMENTAL

Participants will also receive the teaching administered to the control group. In addition, they will be given an Omron Home Blood Pressure Cuff furnished by the study. The nurse will provide additional education on on how to use the cuff, and how to record values in a blood pressure log.

Behavioral: Use of Omron Home Blood Pressure Cuff

Interventions

Use of Omron Home Blood Pressure Cuff BEHAVIORAL

Use of an Omron Home Blood Pressure Cuff to monitor blood pressure after discharge

Access to Blood Pressure Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18 admitted to the Stanford Hospital (SHC) stroke service and discharging to home or acute rehab
• Diagnosis of Ischemic Stroke, Hemorrhagic Stroke, transient ischemic attack (TIA), or otherwise deemed to be at increased risk of stroke by the treating team (for example, asymptomatic carotid stenosis).
• No usable home blood pressure cuff available
• Diagnosis of hypertension or elevated blood pressure (\> 130/80) concerning to the treating clinician for hypertension
• Participant or surrogate able to apply a home blood pressure cuff on the participant
• Patient or Legally Authorized Representative (LAR) agree to participate and are able to consent.

You may not qualify if:

• Currently enrolled in another blood pressure or secondary prevention interventional research study
• Upper arm circumference \> 20 inches
• Any other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94305, United States

RECRUITING

Related Publications (2)

• Ayala C, Tong X, Keenan NL. Regular use of a home blood pressure monitor by hypertensive adults--HealthStyles, 2005 and 2008. J Clin Hypertens (Greenwich). 2012 Mar;14(3):172-7. doi: 10.1111/j.1751-7176.2011.00582.x. Epub 2012 Jan 19.

  PMID: 22372777 BACKGROUND

• Poon IO, Etti N, Lal LS. Does the use of home blood pressure monitoring vary by race, education, and income? Ethn Dis. 2010 Winter;20(1):2-6.

  PMID: 20178174 BACKGROUND

MeSH Terms

Conditions

Hypertension; Stroke; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liron D Kraler, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Christina M Mijalski Sells, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The study protocol includes a cross-over component by which, at the 3 month mark, all study participants will have access to a home blood pressure cuff. This portion of the study will be open-label and observational.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 15, 2023
• Study Start: May 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)