What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, thiazide diuretics, and beta-blockers. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. ARBs may lead to dizziness, hyperkalemia, and kidney issues. Calcium channel blockers often cause swelling in the lower extremities, constipation, and dizziness. Thiazide diuretics can result in electrolyte imbalances, increased urination, and gout. Beta-blockers may cause fatigue, cold extremities, and bradycardia. These side effects should be monitored, especially in home-based blood pressure monitoring programs.

What prior FDA approvals exist?

The FDA has approved several classes of medications for the treatment of high blood pressure, including thiazide diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), and beta-blockers. These medications are often used in combination to achieve optimal blood pressure control. In the context of home-based blood pressure monitoring programs, long-acting agents such as ACE inhibitors (e.g., lisinopril), ARBs (e.g., losartan), and CCBs (e.g., amlodipine) are commonly prescribed due to their efficacy and ease of use, which supports patient adherence and long-term management.

What other types of research exist?

Promising alternatives to Home-Based Blood Pressure Monitoring with continuous monitoring and personalized coaching for high blood pressure patients in 2024 include: 1) Device-guided breathing exercises, which have demonstrated sustained blood pressure reduction. 2) Digital communication methods, such as telemonitoring and mobile health programs, which provide remote monitoring and patient education. 3) Continuous Positive Airway Pressure (CPAP) therapy for patients with obstructive sleep apnea, which can help manage hypertension in this subgroup.

← Back to Search

Mobile Health Program for High Blood Pressure

N/A

Recruiting

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Prescribed use of one or more antihypertensive agents as identified by the International Society of Hypertension core drug-treatment strategy

Be older than 18 years old

Must not have

Planned major surgery, cardiovascular or non-cardiovascular

Heart failure necessitating hospital admission ≤3 months prior to study inclusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a home-based blood pressure monitoring program with health education and coaching to see if it can help reduce cardiovascular disease in rural populations.

Who is the study for?

This trial is for rural residents with uncontrolled high blood pressure who are on hypertension medication and can use a smartphone. They must speak English well enough for the study, not be pregnant or planning pregnancy soon, and not have severe health issues like recent heart failure or life-threatening conditions.

What is being tested?

The study tests a home-based blood pressure monitoring program against regular monitoring plus WebMD app usage. It aims to see if personalized coaching and education help manage hypertension better in rural areas.

What are the potential side effects?

Since this trial involves non-drug interventions like using an app and monitoring devices, side effects may include discomfort from frequent blood pressure checking or stress from self-management of health data.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am taking medication for high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for a major surgery soon.

Select...

I was hospitalized for heart failure within the last 3 months.

Select...

I have not had a heart attack or severe chest pain in the last 3 months.

Select...

I do not have a non-heart related condition expected to be fatal within a year.

Select...

I understand the study's requirements and passed the consent quiz.

Select...

I have had very high blood pressure (over 200/120 mm Hg).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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

Change in systolic and diastolic blood pressure from baseline to 6 months

Secondary study objectives

Adherence to antihypertensive medications

Patient-Reported Outcomes

Pharmaceutical Preparations

+1 more

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

Active Control

Group I: InterventionExperimental Treatment2 Interventions

A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

Group II: Enhanced usual careActive Control2 Interventions

WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

0 / 7Eligibility criteria met

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 ACE inhibitors and ARBs, which relax blood vessels by inhibiting the renin-angiotensin system; calcium channel blockers, which prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels; diuretics, which help the kidneys remove excess sodium and water, reducing blood volume; and beta-blockers, which reduce heart rate and the force of contraction. Understanding these mechanisms is crucial for patients as it helps tailor treatment plans to individual needs, ensuring effective blood pressure control and minimizing side effects, especially when combined with continuous monitoring and personalized coaching.