Recruiting

Blood Pressure Monitor

Sponsor:

Stanford University

Code:

NCT05730465

Conditions

Hypertension

Stroke

TIA

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of Omron Home Blood Pressure Cuff

Study Details

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:

1. Does providing a free home blood pressure cuff improve control of hypertension?
2. Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations?
3. Does improved control of home blood pressure decrease adverse patient outcomes?

Participants will be asked to

  • 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

Study ID

NCT05730465

Start date

May 1, 2023

Status verified date

Apr, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

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.

experimental: Access to Blood Pressure Monitoring

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.

Interventions

Use of Omron Home Blood Pressure Cuff

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

Primary outcome measure

  • Blood pressure [ Time Frame: Month 3 ]
  • Blood pressure [ Time Frame: Month 6 ]

Central Contacts and Locations

Locations

Stanford University Hospital

Recruiting

Palo Alto, California, United States, 94305

Contacts

Lironn Kraler, MD

650-723-7193lkraler@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • Hypertension
  • Stroke
  • TIA
  • Home blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-04-18.