What side effects are associated with this type of intervention?

Common treatments for high blood pressure include lifestyle modifications and medications. Lifestyle changes such as reducing dietary salt intake and increasing physical activity generally have minimal side effects but can sometimes lead to muscle soreness or fatigue. Medications like diuretics, ACE inhibitors, beta-blockers, and calcium channel blockers are also commonly used. Diuretics can cause electrolyte imbalances and dehydration; ACE inhibitors may lead to a persistent cough; beta-blockers can cause fatigue and cold extremities; and calcium channel blockers might result in swelling of the lower extremities and constipation.

What prior FDA approvals exist?

The FDA has approved a variety of medications for the treatment of high blood pressure, including ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics. These medications help manage blood pressure by targeting different physiological pathways. Recently, there has been growing interest in digital health interventions, such as the use of smartwatches and mobile health applications, which aim to improve blood pressure control through behavioral modifications like increased physical activity and reduced salt intake. While these digital interventions are still under study, they represent a promising adjunct to traditional pharmacologic therapies.

What other types of research exist?

Promising, novel alternatives to smartwatch and mobile health applications for high blood pressure patients in 2024 include: 1) Telemedicine platforms that offer personalized care and remote monitoring, 2) Advanced remote patient monitoring systems using non-invasive digital technologies, 3) Dietary interventions supported by AI-driven nutritional coaching, 4) Virtual physical activity programs with real-time feedback, and 5) Pharmacotherapy advancements such as new antihypertensive medications or drug delivery systems.

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mHealth App for High Blood Pressure (myBPmyLife Trial)

N/A

Waitlist Available

Led By Brahmajee K Nallamothu, MD

Research Sponsored by University of Michigan

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 baseline, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a smartwatch and a phone app to help people with high blood pressure be more active and eat less salt by sending them reminders. The goal is to see if these reminders can help lower their blood pressure.

Who is the study for?

This trial is for English-speaking adults with high blood pressure who haven't changed their hypertension medication in the last month. They must own a smartphone compatible with the myBPmyLife app and have internet access. People can't join if they're advised against exercise or low-sodium diets, have very high blood pressure, secondary causes of hypertension, heart failure, kidney disease, issues using a blood pressure cuff or smartwatch due to size, consume less than 1500 mg/day sodium, or are currently/potentially pregnant.

What is being tested?

The study tests whether notifications from a smartwatch and mobile app (myBPmyLife) help people with high blood pressure increase physical activity and reduce salt intake. Participants will be randomly assigned to either receive these interventions through the app or placed in a control group without such features.

What are the potential side effects?

Since this trial involves lifestyle changes delivered via an app rather than medication, side effects may include discomfort from increased physical activity or dietary adjustments but no medicinal side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dietary plus physical activity JITAIExperimental Treatment1 Intervention

Participants in the experimental group will be provided a smarthwatch and home blood pressure monitor. They will then receive the myBPmyLife app that includes push notifications to promote increased physical activity and improve low sodium food choices. The app also provides goal setting for weekly step count and information on low-sodium food choices, as well as feedback on achieving the goals using a dashboard with visualization tools within the mobile application.

Group II: Control armExperimental Treatment1 Intervention

Participants in the control group will be provided a smartwatch and home blood pressure monitor. They will also be provided with general instructions on how to download and install a physical activity and diet regulation applications (apps) available to the general public. They will still be asked to perform the blood pressure monitoring at regularly scheduled time periods, but do not receive the intervention components notifications in myBPmyLife app developed for the experimental group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary and physical activity JITAI delivered through the myBPmyLife app

2021

N/A

~610

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 lifestyle modifications and medications. Lifestyle changes such as reducing dietary salt intake and increasing physical activity can significantly lower blood pressure by decreasing blood volume and improving heart health. Medications like ACE inhibitors, beta-blockers, and diuretics work by relaxing blood vessels, reducing heart rate, and removing excess sodium and water from the body, respectively. Behavioral modifications through notifications, as studied in the Smartwatch and Mobile Health Application trial, are crucial because they help patients adhere to these lifestyle changes consistently, thereby enhancing the effectiveness of treatment and improving overall blood pressure control.

Precision Medicine for Hypertension Patients with Type 2 Diabetes via Reinforcement Learning.Determinants of hypertension treatment adherence among a Chinese population using the therapeutic adherence scale for hypertensive patients.Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial.