What side effects are associated with this type of intervention?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators, inhaled glucocorticoids, theophylline, and antibiotics for exacerbations. Inhaled bronchodilators, such as beta agonists and muscarinic antagonists, can cause side effects like dry mouth, tremors, and palpitations. Inhaled glucocorticoids may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Theophylline can cause nausea, headaches, and arrhythmias, and requires careful monitoring due to its narrow therapeutic range. Antibiotics, used during exacerbations, can result in gastrointestinal disturbances and allergic reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for Chronic Obstructive Pulmonary Disease (COPD), including long-acting beta agonists (LABAs) like indacaterol, long-acting muscarinic antagonists (LAMAs) like tiotropium, and combination therapies such as umeclidinium/vilanterol. These treatments aim to improve lung function and reduce symptoms. While the Community Health Navigators (CHNs) program itself is not a pharmacological treatment, it plays a crucial role in guiding patients through the healthcare system and connecting them to these FDA-approved treatments and other resources, thereby improving overall care and outcomes for patients with COPD.

What other types of research exist?

Promising, novel alternatives to Community Health Navigators for COPD patients in 2024 include: 1) Digital health platforms that offer personalized care plans and real-time monitoring, 2) Telehealth services providing remote consultations and follow-ups, 3) AI-driven care coordination systems that optimize resource allocation and patient management, and 4) Integrated care models that combine multidisciplinary teams and seamless communication between healthcare providers.

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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

Congestive heart failure (at least one instance of a physician billing diagnosis with a relevant ICD-9 code recorded in EMR, or known to health care team)

Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year or labile)

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 a program where trained community members help patients with multiple long-term health conditions navigate the healthcare system. The goal is to improve patient care and outcomes by making it easier for these patients to access necessary services and resources.

Who is the study for?

This trial is for adults with chronic conditions like heart disease, uncontrolled diabetes or high blood pressure, advanced kidney disease, COPD or asthma, and heart failure. They must have had specific diagnoses confirmed by a doctor's records or known to their health care team. People can't join if they live in long-term care facilities, can't consent to the study themselves, or are excluded at their doctor's discretion.

What is being tested?

The ENCOMPASS study is testing a Community Health Navigator Program where trained community members help patients navigate the healthcare system. The goal is to see if this program improves healthcare outcomes for people with multiple long-term health issues when implemented across primary care settings in Alberta.

What are the potential side effects?

Since this trial involves a support program rather than medication, there aren't typical drug side effects. However, participants may experience changes in how they interact with the healthcare system and access services.

Eligibility Criteria

Inclusion Criteria

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

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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.

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I have been diagnosed with heart disease.

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My kidney function is significantly reduced.

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

+22 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

Group I: InterventionExperimental Treatment1 Intervention

Community health navigator program for six months.

Group II: ControlExperimental Treatment1 Intervention

Waitlist control: six-month waiting period followed by six months of community health navigator program.

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

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators and inhaled glucocorticoids. Inhaled bronchodilators, such as beta agonists and muscarinic antagonists, work by relaxing the muscles around the airways, which helps to open them up and make breathing easier. Inhaled glucocorticoids reduce inflammation in the airways, thereby decreasing the frequency and severity of exacerbations. Additionally, community health navigators (CHNs) play a vital role by helping patients navigate the healthcare system and connect to necessary resources, ensuring they receive comprehensive care. This combination of pharmacologic treatment and systemic support is essential for improving the quality of life and health outcomes for COPD patients.

Managing chronic obstructive pulmonary disease in the community setting.The role of patient-centered outcomes in the course of chronic obstructive pulmonary disease: how long-term studies contribute to our understanding.