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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05730465

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Stroke TIA Vascular Diseases	Behavioral: Use of Omron Home Blood Pressure Cuff	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Use of Omron Home Blood Pressure Cuff Use of an Omron Home Blood Pressure Cuff to monitor blood pressure after discharge

Arm

Intervention/Treatment

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.

Behavioral: Use of Omron Home Blood Pressure Cuff

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of stroke [Months 3 and 6]
Patient outcome
Incidence of TIA [Months 3 and 6]
Patient outcome
Any hospitalization [Months 3 and 6]
Patient outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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