HypertensionNCT05730465
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
A study testing Use of Omron Home Blood Pressure Cuff in people with Hypertension and Stroke, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Stroke, TIA
- What is being tested?
- Use of Omron Home Blood Pressure Cuff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University Hospital
Palo Alto, California, 94305
Lironn Kraler, MD, 650-723-7193, lkraler@stanford.edu
About this study
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:
Read more
- 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
Read the 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.
- Conditions
- Hypertension, Stroke, TIA, Vascular Diseases
- Being tested
- Use of Omron Home Blood Pressure Cuff
- Keywords
- Hypertension, Stroke, TIA, Home blood pressure monitoring
- Medical subject headings
- Hypertension, Stroke, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Omron Home Blood Pressure CuffBehavioural
Use of an Omron Home Blood Pressure Cuff to monitor blood pressure after discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Use of Omron Home Blood Pressure Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Home blood pressure measurements provided by patient at month 3
Measured: Month 3
Blood pressure
Home blood pressure measurements provided by patient at month 6
Measured: Month 6
Secondary outcomes (3)
Incidence of stroke
Patient outcome
Measured: Months 3 and 6
Incidence of TIA
Patient outcome
Measured: Months 3 and 6
Any hospitalization
Patient outcome
Measured: Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 May 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Mijalski, Stanford University
- Investigators
- Liron D Kraler, MD, Principal investigator, Stanford UniversityChristina M Mijalski Sells, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730465
- Sponsor's protocol ID
- 68463
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22372777Poon 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.
PubMed 20178174
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
- ClinicalTrials.gov ID
- NCT05730465
- Acronym / sponsor ID
- 68463
- Conditions
- Hypertension, Stroke, TIA, Vascular Diseases
- Keywords
- Hypertension, Stroke, TIA, Home blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Use of Omron Home Blood Pressure CuffParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Omron Home Blood Pressure CuffUse of an Omron Home Blood Pressure Cuff to monitor blood pressure after discharge | Behavioural | Access to Blood Pressure Monitoring |
Primary outcome
Blood pressure
Time frame: Month 3
Home blood pressure measurements provided by patient at month 3
Blood pressure
Time frame: Month 6
Home blood pressure measurements provided by patient at month 6
3 secondary outcomes
Incidence of stroke
Time frame: Months 3 and 6
Incidence of TIA
Time frame: Months 3 and 6
Any hospitalization
Time frame: Months 3 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 22372777Ayala 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.
- Background: PubMed 20178174Poon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liron D Kraler, MD principal investigator
Stanford University
Christina M Mijalski Sells, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Omron Home Blood Pressure Cuff in people with Hypertension and Stroke, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730465, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.