What side effects are associated with this type of intervention?

Common treatments for high blood pressure include medications such as ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Calcium channel blockers can result in swelling, dizziness, and constipation. Diuretics often cause increased urination, electrolyte imbalances, and dehydration. Lifestyle interventions, such as dietary changes and increased physical activity, generally have fewer side effects but may be challenging to maintain and require significant behavioral adjustments.

What prior FDA approvals exist?

The FDA has approved various medications for the treatment of high blood pressure, including ACE inhibitors (e.g., benazepril), angiotensin II receptor blockers (ARBs), calcium channel blockers, and diuretics. These medications are often used in combination to achieve better blood pressure control. Additionally, lifestyle interventions such as diet modification, physical activity, and self-monitoring of blood pressure are recognized as effective strategies to manage hypertension. The trial on self-monitoring with shared medical appointments aims to enhance these lifestyle changes and coping skills to improve blood pressure control.

What other types of research exist?

Promising alternatives for high blood pressure patients in 2024 include: 1) Medication synchronization programs, which improve medication adherence; 2) Appointment reminder systems, which reduce dropout rates and slightly improve blood pressure control; and 3) Digital health interventions, such as mobile apps and telehealth services, which provide real-time monitoring and support for lifestyle changes.

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Home Blood Pressure Monitoring + Lifestyle Education for High Blood Pressure

N/A

Waitlist Available

Led By Irina Todorov, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program where patients with uncontrolled high blood pressure monitor their own blood pressure at home and attend group sessions to learn about healthy living. The goal is to see if this approach helps them manage their blood pressure better. Patients will track their blood pressure, diet, physical activity, and emotions, and receive support from doctors and therapists.

Who is the study for?

This trial is for patients with high blood pressure that isn't controlled by current treatments. They must own a smartphone, be willing to self-report their blood pressure, and be interested in trying lifestyle changes. People can't join if they have extremely high clinic BP readings, are on dialysis, pregnant, terminally ill or have had recent major heart events.

What is being tested?

The study tests whether a program of home blood pressure monitoring combined with a 6-week support course on lifestyle modifications and coping skills can improve hypertension control. Participants will track their BP at home and attend educational sessions led by healthcare professionals.

What are the potential side effects?

Since the intervention involves non-medical approaches like lifestyle education and self-monitoring rather than drugs or medical procedures, there are no direct side effects associated with typical clinical trials. However, participants may experience stress or discomfort from changing habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hypertensive disease

Secondary study objectives

Change in mean BP measured by mm of Hg

Change in mean Self-efficacy scale

Percentage of study participants that adhere to the self-monitoring and lifestyle education program

+2 more

Other study objectives

Mindfulness

Sleeplessness

Change in the mean BP from 12 months before to 12 months after program participation.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Self-monitoring and education program for lifestyle changesExperimental Treatment1 Intervention

Participants will send self-reports of their home BPs, diet, physical activity and emotions while attending a 6-week education program of lifestyle changes and coping skills. Participants will get summary reports of their home BP and lifestyle monitoring. Participants primary care physicians will be notified of persisting high BPs and final average home BP levels. Researchers will monitor home BP levels and change in hypertension control state

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle Modifications

2019

N/A

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include medications and lifestyle changes. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of the renin-angiotensin system, reducing blood pressure. Beta-blockers decrease heart rate and the force of contraction, lowering blood pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels. Diuretics help the body eliminate excess sodium and water, reducing blood volume and pressure. Lifestyle changes, such as a healthy diet, regular exercise, and stress management, are crucial as they address the root causes of hypertension. These mechanisms are important because they help prevent complications like heart disease and stroke. The self-monitoring and lifestyle education approach in the trial emphasizes patient involvement in managing their condition, which can lead to better adherence and outcomes.