What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) include revascularization procedures such as stenting and coronary artery bypass grafting (CABG), and drug therapies like statins and antihypertensive medications. Revascularization procedures can lead to side effects such as bleeding, infection, and restenosis. Statins may cause muscle pain, liver damage, and increased blood sugar levels. Antihypertensive medications can have side effects including dizziness, fatigue, and electrolyte imbalances. Patient navigation programs like Community Health Navigators (CHNs) help manage these treatments by guiding patients through the healthcare system and connecting them to necessary resources, potentially improving adherence and outcomes.

What prior FDA approvals exist?

The FDA has approved several drug classes for the treatment of Coronary Artery Disease (CAD), including antiplatelet agents (e.g., aspirin, clopidogrel), beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins for lipid lowering. These medications help manage symptoms, reduce the risk of heart attacks, and improve overall cardiovascular health. Additionally, patient navigation programs like Community Health Navigators (CHNs) play a crucial role in guiding patients through the healthcare system, ensuring they receive appropriate treatments and resources, which can lead to better management of CAD and improved patient outcomes.

What other types of research exist?

Promising, novel alternatives to Community Health Navigators (CHNs) for Coronary Artery Disease (CAD) patients include: 1) Telemedicine platforms that offer remote monitoring and virtual consultations, improving access to care and continuous patient engagement. 2) Mobile health applications that provide personalized health tracking, medication reminders, and educational resources. 3) Integrated care models that combine primary care with specialized cardiac care, ensuring a coordinated approach to treatment. 4) Use of Artificial Intelligence (AI) to analyze patient data and provide tailored recommendations and early intervention alerts. These alternatives can enhance patient support and resource connection in 2024.

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Community Health Navigator Program for Chronic Conditions (ENCOMPASS Trial)

N/A

Waitlist Available

Led By Kerry A McBrien, MD, MPH

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Stage 3b or greater chronic kidney disease (estimated glomerular filtration rate < 45 mL/min/1.73m2 in past year)

Established ischemic heart disease (at least one instance of a physician billing diagnosis with a relevant International Classification of Diseases, 9th Edition [ICD-9] code recorded in electronic medical record (EMR), or known to health care team)

Must not have

Patient unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the effectiveness of Community Health Navigators (CHNs) in helping patients with multiple long-term health conditions. CHNs are trained community members who guide patients through the healthcare system and connect them to essential resources. The study aims to see if this program can be expanded across Alberta to improve patient care and outcomes.

Who is the study for?

This trial is for individuals with multiple long-term health conditions like severe high blood pressure, heart failure, ischemic heart disease, advanced kidney disease (stage 3b or greater), COPD or asthma with frequent visits, and poorly controlled diabetes. Participants must be able to consent and not live in a long-term care facility.

What is being tested?

The ENCOMPASS study tests a Community Health Navigator Program where trained community members help patients navigate the healthcare system. It aims to improve access to services for those with complex health conditions in Alberta.

What are the potential side effects?

Since this intervention involves guidance rather than medication, typical drug side effects are not expected. However, there may be indirect effects related to changes in healthcare utilization.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is reduced, with a filtration rate below 45 mL/min.

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I have been diagnosed with heart disease.

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I have been diagnosed with congestive heart failure.

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My diabetes has been poorly controlled, with an A1C over 9% in the past year.

Exclusion Criteria

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

Select...

I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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

Acute care service use

Secondary study objectives

Acute care costs

All-cause mortality

Anxiety symptoms

+21 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 Treatment1 Intervention

Community health navigator program for six months.

Group II: ControlActive Control1 Intervention

Usual health care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Community Health Navigator Program

2021

N/A

~340

0 / 5Eligibility 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 Coronary Artery Disease (CAD) include statins, antiplatelet agents, and antihypertensive medications. Statins work by lowering low-density lipoprotein cholesterol (LDL-C) levels, which helps reduce plaque buildup in the arteries. Antiplatelet agents, such as aspirin, prevent blood clots by inhibiting platelet aggregation, thereby reducing the risk of heart attacks. Antihypertensive medications help manage blood pressure, decreasing the strain on the heart and arteries. These treatments are essential for CAD patients as they address the underlying causes and complications of the disease. Community Health Navigators (CHNs) play a vital role in ensuring patients access these treatments by guiding them through the healthcare system and connecting them to necessary resources.

Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes?