search
Back to results

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

Primary Purpose

Hypertension, Stroke, TIA

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of Omron Home Blood Pressure Cuff
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Stroke, TIA, Home blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Access to Blood Pressure Monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure
Home blood pressure measurements provided by patient at month 3
Blood pressure
Home blood pressure measurements provided by patient at month 6

Secondary Outcome Measures

Incidence of stroke
Patient outcome
Incidence of TIA
Patient outcome
Any hospitalization
Patient outcome

Full Information

First Posted
January 27, 2023
Last Updated
September 6, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT05730465
Brief Title
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
Official Title
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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: Does providing a free home blood pressure cuff improve control of hypertension? Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations? 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
Detailed Description
Patients with a history of hypertension and a history stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or otherwise are at high risk of stroke will be screened for enrollment. Inclusion and exclusion criteria will be reviewed and confirmed by a member of the study team. If the patient meets criteria, the following will occur: A member of the study team (physician, nurse, study coordinator) will describe the study to the patient and inform them of their candidacy. If the patient indicates interest in study participation, the patient will be provided a written or electronic consent form to review and sign. The patient will be randomized to one of two arms in the study. Upon enrollment, the patient will complete an intake survey. Prior to hospital discharge, patients randomized to arm 1 (control) of the study will receive routine stroke discharge education which is standard of care. In addition to standard of care, a stroke nurse will provide and review with the patient a short informational pamphlet (included in the attachments) on the importance of blood pressure monitoring. Patients randomized to arm 2 (intervention) will also receive this teaching as above. 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. At three months following enrollment, a member of the study team will call the patients in both arms to complete a questionnaire (included in the attachments) over the phone and provide a blood pressure reading using their home blood pressure cuff. If needed, a phone interpreter will be used. At three months, patients randomized to arm 1 of the study will receive a blood pressure cuff in the mail with written instructions on how to use it. At six months following enrollment, a member of the study team will call the patients in both arms to complete a questionnaire over the phone and provide a blood pressure reading using their home blood pressure cuff. If needed, a phone interpreter will be used. The patient will be notified that the duration of their participation in the study has ended. All study materials given to the patient are theirs to keep. A chart review will be conducted for the study participants to supply information about health outcomes incurred throughout the duration of the study, and to obtain blood pressure readings from ambulatory visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stroke, TIA, Vascular Diseases
Keywords
Hypertension, Stroke, TIA, Home blood pressure monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Access to Blood Pressure Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Use of Omron Home Blood Pressure Cuff
Intervention Description
Use of an Omron Home Blood Pressure Cuff to monitor blood pressure after discharge
Primary Outcome Measure Information:
Title
Blood pressure
Description
Home blood pressure measurements provided by patient at month 3
Time Frame
Month 3
Title
Blood pressure
Description
Home blood pressure measurements provided by patient at month 6
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Incidence of stroke
Description
Patient outcome
Time Frame
Months 3 and 6
Title
Incidence of TIA
Description
Patient outcome
Time Frame
Months 3 and 6
Title
Any hospitalization
Description
Patient outcome
Time Frame
Months 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liron D Kraler, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina M Mijalski Sells, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lironn Kraler, MD
Phone
650-723-7193
Email
lkraler@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22372777
Citation
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.
Results Reference
background
PubMed Identifier
20178174
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs