Technology Intervention for High Blood Pressure

Overseen By Carolyn Still, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must be taking: Diuretics, Calcium channel blockers

Disqualifiers: Cognitive impairment, CVD event, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how mobile health technology can help African American older adults better manage high blood pressure. The study will use a smartphone app, the OPTIMA-BP Intervention, to improve medication adherence and blood pressure control. Participants will either start the intervention immediately or after a six-month waitlist period. African Americans aged 50 or older, diagnosed with high blood pressure, and who own a smartphone might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance health management for many.

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 prior data suggests that this technology intervention is safe for managing high blood pressure?

Research has shown that the OPTIMA-BP program, which uses technology to manage high blood pressure, has been promising in earlier studies. This program involves checking blood pressure at home and using mobile health tools like phone apps and text messages to assist with medication adherence and better blood pressure control.

In previous studies, participants generally found these digital methods easy to use. Although specific details about side effects or safety issues aren't provided, technology for managing long-term health conditions is usually considered safe. Since the trial phase isn't mentioned, it is important to note that the treatment is still in early testing for this specific purpose. However, similar technology-based methods have been used safely in other contexts.

While detailed safety information for the OPTIMA-BP program isn't fully available, technology in health management has a history of being safe and well-accepted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPTIMA-BP intervention because it leverages technology to manage high blood pressure, a fresh approach compared to traditional options like medication and lifestyle changes. This intervention is unique because it incorporates personalized strategies using digital tools to monitor and adjust treatment in real-time, potentially improving patient engagement and outcomes. By focusing on technology-driven solutions, OPTIMA-BP aims to enhance the effectiveness of blood pressure management and provide more tailored care for individuals.

What evidence suggests that the OPTIMA-BP intervention is effective for managing high blood pressure?

Studies have shown that checking blood pressure at home and watching educational videos can improve blood pressure control. Research indicates that when patients learn to manage high blood pressure, they often experience better health outcomes. Early results suggest that the OPTIMA-BP program, tested in this trial, uses technology to help people take their medication and manage their health effectively. This method shows particular promise for older African American adults, who often face challenges in managing high blood pressure. The goal is to enhance blood pressure control and reduce health disparities between racial groups. Participants in this trial will receive the OPTIMA-BP intervention either immediately or after a waitlist period. ^{1 2 3 5 6}

Who Is on the Research Team?

Carolyn Still, PhD

Principal Investigator

Case Western Reserve University, School of Nursing

Are You a Good Fit for This Trial?

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

Self-identify as African American

My blood pressure is between 130/80 and 160/90 mmHg.

Own a smartphone with a data plan, the capability to download the Medisafe app, or view videos

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OPTIMA-BP intervention for 6 months

6 months

Regular virtual check-ins using mHealth platforms

Follow-up

Participants are monitored for blood pressure control and health-related quality of life

6 months

Periodic virtual assessments

Waitlist Control

Participants are on a waitlist for 6 months before receiving the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• OPTIMA-BP Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention: OPTIMA-BP Implementation Experimental Treatment 1 Intervention

Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period

Group II: Waitlist: OPTIMA-BP implementation Active Control 1 Intervention

Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Published Research Related to This Trial

The program combining electronic home blood pressure monitoring and pharmacist-provided medication therapy management led to significant reductions in both systolic and diastolic blood pressure in 50 renal transplant recipients over one year, indicating improved blood pressure control (p < 0.05).

The involvement of a dedicated pharmacist in the renal transplant clinic helped identify and resolve medication-related issues in 46% of cases, enhancing medication adherence and overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving blood pressure control among renal transplant recipients by integrating electronic health technology and clinical pharmacy services. Migliozzi, DR., Zullo, AR., Collins, C., et al.[2019]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

A study involving 236 hypertensive patients found that antihypertensive treatment guided by telemonitoring of home blood pressure was as effective as traditional office-based monitoring in reducing systolic daytime blood pressure over 6 months.

Both groups experienced significant decreases in blood pressure, with the telemonitoring group showing a reduction of -11.9 mmHg compared to -9.6 mmHg in the control group, indicating that home monitoring can be a viable alternative for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. Madsen, LB., Kirkegaard, P., Pedersen, EB.[2008]

Patients showed a significant increase in their knowledge of blood pressure and comfort with technology after using a Bluetooth-enabled BP monitor and receiving weekly telehealth counseling from pharmacists during a 6-week study involving 12 participants.

The study suggests that integrating Bluetooth BP monitors with pharmacist interventions can enhance blood pressure control and improve patient outcomes, as evidenced by positive patient feedback and improved lifestyle modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacists interventions using Bluetooth technology and telehealth to improve blood pressure-A pilot study. Updike, WH., Pane, O., Hanna, K., et al.[2021]

Home blood pressure telemonitoring (HBPT) has been shown to improve patient compliance and hypertension control rates, based on randomized controlled trials, although the overall evidence for blood pressure reduction is considered 'moderate'.

Despite the potential of digital health interventions, there is a lack of high-quality evidence regarding the accuracy and safety of mobile applications for hypertension management, indicating that not all available apps are suitable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. Postel-Vinay, N., Bobrie, G., Asmar, R., et al.[2023]

Home blood pressure monitoring (HBPM) is an effective self-monitoring tool for managing hypertension, leading to better blood pressure control and helping to identify conditions like white-coat hypertension, as supported by a growing body of evidence.

New HBPM technology features a longer inflatable cuff that improves accuracy by allowing for better placement on the arm, addressing the common issue of inaccurate readings in traditional monitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Monitoring. George, J., MacDonald, T.[2022]

A multidisciplinary approach involving patients, doctors, and pharmacists, along with telemonitoring, could significantly improve blood pressure control and cardiovascular outcomes, addressing the issue that many patients do not reach ideal blood pressure targets.

Improved renal denervation techniques and understanding the impact of blood pressure variability on cognitive health highlight the need for better management strategies in hypertension, especially in vulnerable populations like pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hypertension: novelties 2020]. Berney, M., Wuerzner, G., Ponte, B., et al.[2021]

Home blood pressure (BP) telemonitoring significantly enhances patient awareness and management of hypertension, leading to improved BP control rates, especially when combined with self-adjustment based on treatment algorithms.

Telemonitoring that includes active intervention from healthcare professionals not only boosts medication compliance but also increases the likelihood of achieving target BP levels, making it a valuable tool alongside traditional doctor-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. Lee, CJ., Park, S.[2022]

A study involving 232 patients with mild-to-moderate hypertension showed that home blood pressure monitoring (HBPM) significantly reduced therapeutic inertia (TI) compared to standard care, with TI rates dropping from 50% in the control group to 25.23% in the intervention group by the final visit.

The intervention was effective in managing hypertension, as evidenced by a mean number needed to intervene (NI) of 4.3, indicating that for every 4.3 patients monitored at home, one less experienced therapeutic inertia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring]. Márquez Contreras, E., Martín de Pablos, JL., Espinosa García, J., et al.[2021]

Ambulatory blood pressure monitoring (ABPM) studies can accurately measure blood pressure changes over 24 hours in patients with cardiovascular risk, providing valuable data for assessing the safety of chronic medications.

These studies help in developing quantitative safety models to predict cardiovascular risk, which can aid in dose selection and identifying patients who may experience significant blood pressure responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining Blood Pressure Assessment - The Role of the Ambulatory Blood Pressure Monitoring Study for Drug Safety. Garnett, C., Johannesen, L., McDowell, TY.[2020]

Home-based blood pressure telemonitoring has been shown to effectively reduce blood pressure levels and improve patient satisfaction, making it a valuable tool for managing hypertension.

Further research is necessary to evaluate the cost-effectiveness and long-term clinical outcomes of home-based blood pressure monitoring, especially when combined with behavioral modifications and medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of home blood pressure telemonitoring in managing hypertensive populations. Zullig, LL., Melnyk, SD., Goldstein, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910568/

OPTIMA-BP: empOwering PaTients in MAnaging Blood ... The use of home BP monitoring (HBPM) in conjunction with BP education through video-based delivery has been shown to be effective in improving ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05575453

OPTIMA-BP: Empowering PaTients in MAnaging Blood ... Empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead ...

3. dovepress.com dovepress.com/optimizing-technology-to-improve-medication-adherence-and-bp-control-o-peer-reviewed-fulltext-article-NRR

OPtimizing Technology to Improve Medication Adherence ... The objective of this study is to test the efficacy of a TBI, OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP),

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05293756/optimizing-technology-to-improve-medication-adherence-and-bp-control-optima-bp

OPtimizing Technology to Improve Medication Adherence ... OPTIMA-BP investigates the effectiveness of a technology-based intervention (TBI) for hypertension self-management and to improve blood ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061496/

OPtimizing Technology to Improve Medication Adherence ... The objective of this study is to test the efficacy of a TBI, OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP), ...

6. gla.ac.uk gla.ac.uk/colleges/mvls/livinglab/our-projects/digital-health-validation-lab/projects/optima-bp/

OPTIMA-BP: empowering patients in managing blood ... By capturing participants' HBPM results, the OPTIMA-BP study aims to compare systolic blood pressure (SBP) between the standard care and intervention group.