Technology Intervention for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a mobile health program called OPTIMA-BP that helps older African American adults manage their high blood pressure. The program uses smartphones and text messages to remind patients to take their medications and follow healthy habits. The goal is to improve blood pressure control and overall health in this high-risk group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that you are already prescribed at least two antihypertensive medications, including a diuretic or calcium channel blocker.
What data supports the effectiveness of the OPTIMA-BP Intervention treatment for high blood pressure?
Research shows that home blood pressure telemonitoring, which is a key component of the OPTIMA-BP Intervention, helps people better control their blood pressure and feel more satisfied with their care. This approach uses technology to track blood pressure at home and has been linked to improved blood pressure management.
12345Is the Technology Intervention for High Blood Pressure safe for humans?
Home blood pressure telemonitoring, a component of the intervention, is generally safe and associated with improved blood pressure control and patient satisfaction. However, more research is needed to fully understand its long-term safety and effectiveness.
13678How is the OPTIMA-BP Intervention treatment for high blood pressure different from other treatments?
The OPTIMA-BP Intervention is unique because it uses technology to monitor blood pressure at home and involves telemonitoring, which allows healthcare professionals to remotely track and adjust treatment. This approach can improve patient compliance and blood pressure control by providing real-time feedback and support, unlike traditional methods that rely solely on in-person doctor visits.
4591011Eligibility Criteria
This trial is for African American individuals over 50 with high blood pressure (BP≥130/80 but <160/90 mmHg), taking at least two BP medications including a diuretic or calcium channel blocker, and who own a smartphone. It's not for those who've had major cardiovascular events in the past year, have cognitive impairments, use other medication apps, show high BP variability, or have severe kidney disease.Inclusion Criteria
I am taking two blood pressure medicines, including a water pill or calcium blocker.
I am 50 years old or older.
Exclusion Criteria
I have chronic kidney disease or am on dialysis.
I am able to understand and consent to my treatment.
I had a major heart event or surgery in the last year.
Participant Groups
The OPTIMA-BP trial tests an intervention using mobile health technologies to improve medication adherence and manage high blood pressure among older African Americans. The study aims to see if this tech-based support can help control BP better and reduce health disparities.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: OPTIMA-BP ImplementationExperimental Treatment1 Intervention
Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period
Group II: Waitlist: OPTIMA-BP implementationActive Control1 Intervention
Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Case Western Reserve UniversityCleveland, OH
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Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
University Hospitals Cleveland Medical CenterCollaborator
References
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.
Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]To compare the effectiveness of antihypertensive treatment based on telemonitoring of home blood pressure (BP) and conventional monitoring of office BP.
The role of home blood pressure telemonitoring in managing hypertensive populations. [2023]Hypertension is a common chronic disease affecting nearly one-third of the United States population. Many interventions have been designed to help patients manage their hypertension. With the evolving climate of healthcare, rapidly developing technology, and emphasis on delivering patient-centered care, home-based blood pressure telemonitoring is a promising tool to help patients achieve optimal blood pressure (BP) control. Home-based blood pressure telemonitoring is associated with reductions in blood pressure values and increased patient satisfaction. However, additional research is needed to understand cost-effectiveness and long-term clinical outcomes of home-based BP monitoring. We review key interventional trials involving home based BP monitoring, with special emphasis placed on studies involving additionally behavioral modification and/or medication management. Furthermore, we discuss the role of home-based blood pressure telemonitoring within the context of the patient-centered medical home and the evolving role of technology.
[Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring]. [2021]To evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT).
Pharmacists interventions using Bluetooth technology and telehealth to improve blood pressure-A pilot study. [2021]To assess patients' knowledge of blood pressure (BP) and their comfort level with using technology, including a Bluetooth-enabled BP device and pharmacist telemonitoring. The secondary objective was to discover if pharmacist interventions improved BP readings.
Redefining Blood Pressure Assessment - The Role of the Ambulatory Blood Pressure Monitoring Study for Drug Safety. [2020]According to models developed from large epidemiological studies, mean increases in systolic blood pressure of 2-3 mmHg can increase the risk of cardiovascular (CV) adverse events, especially in patients with a high risk for CV disease. There are new regulatory recommendations for the use of a safety ambulatory blood pressure monitoring (ABPM) study to assess the blood pressure (BP) effects of drugs used chronically. The ABPM study collects BP measurements over 24 hours at baseline and during treatment in patients with underlying CV risk. Our evaluation of ABPM studies submitted to the US Food and Drug Administration (FDA) shows these studies can provide precise estimates of BP changes and lack a pronounced placebo response. With the assessment of BP effects in development programs, opportunities exist for developing quantitative safety models to predict CV risk, support dose selection, identify patients with increased BP response, and provide insight into underlying mechanisms.
Home Blood Pressure Monitoring. [2022]Hypertension is the most common preventable cause of cardiovascular disease. Home blood pressure monitoring (HBPM) is a self-monitoring tool that can be incorporated into the care for patients with hypertension and is recommended by major guidelines. A growing body of evidence supports the benefits of patient HBPM compared with office-based monitoring: these include improved control of BP, diagnosis of white-coat hypertension and prediction of cardiovascular risk. Furthermore, HBPM is cheaper and easier to perform than 24-hour ambulatory BP monitoring (ABPM). All HBPM devices require validation, however, as inaccurate readings have been found in a high proportion of monitors. New technology features a longer inflatable area within the cuff that wraps all the way round the arm, increasing the 'acceptable range' of placement and thus reducing the impact of cuff placement on reading accuracy, thereby overcoming the limitations of current devices.
[Hypertension: novelties 2020]. [2021]Nowadays, hardly half of treated patients do not reach ideal blood pressure targets. New approaches could help, such as the creation of a multidisciplinary network of patients, doctors, pharmacists, with the favorable effects of telemonitoring on blood pressure control and cardiovascular outcomes. An excessive fall of blood pressure (BP) after a hemorrhagic stroke, when systolic BP is superior to 220 mm Hg, is deleterious. Improvement of renal denervation techniques, along with indications expansion, will complete the arsenal of care. Hypertensive pregnant women transmit BP values to their offsprings, leading to earlier prevention. Finally, visit-to-visit BP variability puts a considerable strain on the cognitive risk and dementia of hypertensive people.
The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. [2022]Despite improvements in hypertension awareness and treatment, the blood pressure (BP) control rate still remains at around 50%. One of the major determinants of low BP control results from therapeutic inertia of the physician and suboptimal compliance of the patients. Home BP self-measurement and monitoring improves patients' awareness and helps the management of hypertension. Recent technological advances are allowing for accurate measurement and telemonitoring of home BP, with a number of randomized clinical trials demonstrating the efficacy of telemonitoring for BP control. Home BP telemonitoring combined with self-adjustment based on prespecified treatment algorithms has been shown to improve BP control. Additionally, telemonitoring with active intervention by medical professionals has been shown to improve drug compliance and increase the target BP achievement rate. Although nothing can replace the tried and tested doctor-patient relationship in the office, telemonitoring of home BP will be an important tool for treating hypertension in the future.
Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]The development of mobile telephones has made it possible to design blood pressure (BP) monitors with data transmission via cellular lines, contributing to the emergence of "e-health". Today, the direct-to-consumer marketing of devices create a new context allowing an algorithmic processing of information for remote decision-making either by the patient or by a healthcare professional. The home BP telemonitoring (HBPT) is the remote transmission of BP values, measured at home and transmitted to the doctor's office or hospital, by means of telehealth strategies. In this context, randomized controlled trials (RCTs) studies have demonstrated HBPT ability in improving patients' compliance and adherence to treatment and in accomplishing better hypertension control rates. The level of evidence for the drop in BP is "moderate" and the place of HBPT is not clearly established in current practice. Digital interventions have the potential to support patient in self-management. This approach presupposes the prior acquisition of skills, the level of which must be adapted to the level of health literacy of each patient. Few of medical applications (mobile apps or web-apps) for hypertension can be regarded as accurate and safe for clinical use and to date, we do not have high quality evidence to determine the overall effect of the use smartphone apps on BP control.
Achieving blood pressure control among renal transplant recipients by integrating electronic health technology and clinical pharmacy services. [2019]The implementation and outcomes of a program combining electronic home blood pressure monitoring (HBPM) and pharmacist-provided medication therapy management (MTM) services in a renal transplantation clinic are described.