4 Participants Needed

ACT-BP Intervention for High Blood Pressure

(ACT-BP Trial)

Recruiting at 1 trial location
EP
Overseen ByElizabeth Pfoh, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Elizabeth Pfoh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a specific approach called ACT-BP, a blood pressure management plan, can effectively manage high blood pressure in hospital patients without causing harm from excessive medication. It focuses on patients with high blood pressure readings in the hospital who do not exhibit symptoms like chest pain or severe headaches. Participants will either join a group where nurses follow a specific blood pressure management plan or a control group receiving usual care. The trial seeks patients hospitalized for less than 10 days, with blood pressure readings between 160 mmHg and 199 mmHg, and without serious heart or kidney issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hospital care for future patients.

What prior data suggests that the ACT-BP intervention is safe for managing asymptomatically elevated blood pressure?

Research shows that the ACT-BP Intervention aims to manage high blood pressure in asymptomatic individuals. Although specific evidence on the safety of this exact method is lacking, similar approaches have been safely used in other contexts to control blood pressure. These methods focus on better blood pressure management without increasing medication, helping to avoid the side effects of additional drugs.

Since this study is not in a specific trial phase, complete safety data is not yet available. However, interventions like ACT-BP, which aim to reduce unnecessary medication, are generally well-tolerated. They prioritize education and decision-making over direct medical treatment, potentially leading to fewer side effects by avoiding unnecessary medications. It is important to consult a healthcare provider to understand this approach and its potential effects.12345

Why are researchers excited about this trial?

Researchers are excited about the ACT-BP Intervention because it introduces a proactive approach to managing asymptomatic high blood pressure, specifically targeting blood pressure levels between 160mmHg and 199mmHg. Unlike traditional treatment options that may focus primarily on medicating high blood pressure, the ACT-BP protocol employs an algorithm and educational tools to guide nurses and caregivers in addressing underlying causes without immediate medication. This method aims to enhance adherence to best practices and improve patient outcomes by providing relevant knowledge and resources to healthcare providers, potentially reshaping the management of high blood pressure in non-emergency situations.

What evidence suggests that the ACT-BP intervention is effective for managing asymptomatically elevated blood pressure?

Research has shown that the ACT-BP program, which participants in this trial may receive, might help manage high blood pressure without increasing medication use. Studies have found that lowering high blood pressure during regular doctor visits can lead to long-lasting improvements, with benefits observed 10 to 24 months after starting the program. One study found that beginning treatment early, within the first month of diagnosis, led to positive results 6 to 30 months later. In another study, more patients had their high blood pressure under control after a management program, with an increase from 53.4% to 57.3%. These findings suggest that the ACT-BP program could effectively manage high blood pressure by focusing on timely and appropriate treatment without excessive reliance on medication.13567

Who Is on the Research Team?

EP

Elizabeth Pfoh, PhD, MPH

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients admitted to certain hospital units who have high blood pressure readings during their stay but aren't showing symptoms. Units that usually handle more critical step-down care are not included in the study.

Inclusion Criteria

My care unit does not usually handle step-down care patients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the ACT-BP protocol in intervention units, including education and removal of standing orders for antihypertensive medication intensification

13 months
Ongoing monitoring during hospitalization

Control

Care continues as usual in control units with educational materials provided

13 months
Ongoing monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACT-BP Intervention

Trial Overview

The ACT-BP Intervention is being tested to see if it can reduce the need for increasing blood pressure medication in hospitalized patients with high blood pressure who don't have symptoms. The goal is to inform future guidelines on managing elevated BP without causing harm.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elizabeth Pfoh

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Long-term outcomes of a one-year hypertension quality ...

Two studies that focused on reducing elevated BP within the primary care setting found that BP control gains were retained 10 to 24 months post-intervention. We ...

Treatment in the First Month After Hypertension Diagnosis ...

TI within the first month after diagnosis in contrast to later time points, leads to better BP control at 6 to 30 months, which is associated with better ...

Evaluating Whether Treating Elevated Blood Pressure in ...

The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is ...

Effectiveness evaluation of a hypertension management ...

Results showed that 53.4% of patients had controlled hypertension pre-intervention (September 2016-September 2018); 57.3% had controlled hypertension at the end ...

Health and Economic Benefits of High Blood Pressure ...

Adopting self-measured blood pressure monitoring programs could reduce heart attacks by 4.9% and strokes by 3.8%, and could generate $7,794 ...

BP MAP A Pragmatic Cluster Randomized Trial

Outcomes were clinic‐level BP control (<140/90 mm Hg) and other BP‐related process metrics calculated using electronic health record data.

Act Rapidly

This resource will help you act rapidly in managing your patients elevated blood pressure by explaining what tools are available to you.