What side effects are associated with this type of intervention?

Common treatments for high blood pressure, such as ACE inhibitors, calcium channel blockers (CCBs), and diuretics, have well-documented side effects. ACE inhibitors can cause cough, elevated blood potassium levels, and, in rare cases, angioedema. CCBs may lead to peripheral edema, dizziness, and constipation. Diuretics, particularly thiazide diuretics like hydrochlorothiazide, can result in electrolyte imbalances, such as low potassium levels, and increased urination. These side effects are generally manageable but should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, many of which are similar to those being studied in the Adapted Kaiser Bundle. These include ACE inhibitors such as enalapril and lisinopril, ARBs like losartan and valsartan, calcium channel blockers such as amlodipine, and thiazide diuretics like hydrochlorothiazide. These medications have been shown to be effective in controlling blood pressure and are commonly used in various treatment regimens to manage hypertension.

What other types of research exist?

Promising alternatives to the Adapted Kaiser Bundle for hypertension control in 2024 include: 1) Bedtime Hypertension Chronotherapy (BTCT), which targets normalization of asleep blood pressure and has shown significant cardiovascular risk reduction in trials like HOPE and MAPEC; 2) Stratified Medicine approaches, which use prediction models to tailor intensive antihypertensive treatment based on individual benefit-risk profiles; and 3) Community health worker-led interventions, which leverage local resources and personalized care to improve blood pressure control in underserved populations.

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Behavioral Intervention

Practice Facilitation for High Blood Pressure (CIRCL-Chicago Trial)

N/A

Waitlist Available

Research Sponsored by Northwestern University

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 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to adapt a proven set of methods to manage high blood pressure for use in the South Side of Chicago. It focuses on minority residents who have high rates of hypertension. Community health workers and church facilitators will help manage blood pressure with support from local clinics and shared data.

Who is the study for?

This trial is for adults aged 18-89 living in Chicago's South and West Sides, who are patients within participating clinics or churches. It aims to help those affected by high blood pressure and cardiovascular disease, especially minority populations.

What is being tested?

The study tests a community-centered health intervention adapted from Kaiser Permanente's model. It includes simplified treatment regimens and support from local health workers, with the goal of improving blood pressure control through faith-based organizations.

What are the potential side effects?

Since this trial focuses on implementing a healthcare strategy rather than testing new medications, it does not have direct medical side effects. However, there may be indirect impacts related to changes in healthcare delivery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Blood pressure

Secondary study objectives

Acceptability of Intervention Measure

Feasibility of implementation

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: Practice FacilitationExperimental Treatment1 Intervention

Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle

Group II: Non-Practice FacilitationActive Control1 Intervention

implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation

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 ACE inhibitors, which block the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby relaxing blood vessels. ARBs (Angiotensin II Receptor Blockers) prevent angiotensin II from binding to its receptors, also leading to vasodilation. Calcium channel blockers inhibit calcium ions from entering vascular smooth muscle cells, causing relaxation and reduced vascular resistance. Diuretics help the kidneys remove excess sodium and water from the body, decreasing blood volume and pressure. Beta-blockers reduce heart rate and the force of contraction, lowering blood pressure. These mechanisms are essential for managing high blood pressure to prevent complications like stroke and heart disease.

Cerebrovascular protection and antihypertensive therapy.