What side effects are associated with this type of intervention?

Common treatments for COPD include pulmonary rehabilitation, inhaled bronchodilators, inhaled corticosteroids, and continuous monitoring. Pulmonary rehabilitation, which involves exercise training and breathing techniques, generally has minimal side effects but may cause muscle soreness or fatigue. Inhaled bronchodilators, such as beta-agonists and anticholinergics, can cause dry mouth, tremors, and palpitations. Inhaled corticosteroids may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Continuous monitoring and integrated care typically have no direct side effects but require patient adherence and can sometimes lead to anxiety or stress related to constant health tracking.

What prior FDA approvals exist?

The FDA has approved several treatments for COPD that align with the components of the Program of Care. These include long-acting bronchodilators such as tiotropium (Spiriva) and indacaterol (Arcapta), which help manage symptoms and improve lung function. Inhaled corticosteroids like fluticasone (Flovent) are also approved for reducing inflammation. For continuous monitoring and coordinated care, devices like the Propeller Health sensor, which tracks inhaler use and provides data to healthcare providers, have been cleared by the FDA. Pulmonary rehabilitation programs, although not FDA-regulated, are widely recommended and include exercise training, nutritional advice, and education to improve overall health and quality of life for COPD patients.

What other types of research exist?

Promising, novel alternatives to the Program of Care for COPD patients include: 1) Tele-rehabilitation programs that use home tele-monitoring to empower patients and provide continuous support. 2) Home-based exercise programs, including both interval and continuous aerobic exercise, tailored to individual patient needs. 3) Integrated care models that combine patient, professional, and organizational interventions to enhance care coordination. 4) Use of digital health diaries and remote consultations to monitor patient progress and adjust treatment plans in real-time. These alternatives leverage technology to provide personalized, accessible, and effective COPD management.

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Behavioral Intervention

Program of Care for COPD

N/A

Recruiting

Led By Robert Wu, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma

Significant cognitive impairment and absence/inability of a family caregiver to consent and to follow study processes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program for COPD patients. The program includes online exercises, coordinated care from different healthcare providers, and remote health monitoring to help them stay healthy at home.

Who is the study for?

This trial is for patients with COPD who were recently discharged after a severe flare-up and referred to Virtual Pulmonary Rehabilitation or Remote Clinical Monitoring at Toronto Grace Health Centre. It's not for those with other major lung diseases, very short life expectancy, or significant cognitive issues without caregiver support.

What is being tested?

The CHARM-COPD program includes virtual pulmonary rehabilitation, integrated care, and remote monitoring using tools like the Hyfe Smartwatch, Home Spirometer, FitBit Versa 2, and audio recording to manage COPD after hospital discharge.

What are the potential side effects?

Since this trial involves non-invasive monitoring devices and virtual programs rather than medications, typical drug side effects are not expected. However, participants may experience discomfort or inconvenience from wearing devices.

Eligibility Criteria

Exclusion Criteria

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

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My main lung problem is not COPD, but another condition like asthma.

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I have severe memory or thinking problems and no family caregiver to help with study requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability by patients and clinicians

Actual usage over 90 days

Feasibility of the program and research study

Secondary study objectives

Readmissions within 30 days

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Full study interventionExperimental Treatment4 Interventions

In addition to the standard of care at the institutions which includes virtual pulmonary rehabilitation, remote clinical monitoring and integrated care, patients will have the option to use the following interventions: * FitBit wearable device with continuous monitoring for oxygen saturation and respiratory rate for 90 days * Hyfe cough monitoring smartwatch with continuous monitoring for 90 days * Home spirometer used once daily for 90 days * Audio recordings on a tablet once daily for 90 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Audio recording

2020

Completed Phase 1

~130

0 / 2Eligibility 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 Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, pulmonary rehabilitation, and coordinated care. Bronchodilators relax the airway muscles, improving airflow and reducing breathlessness. Inhaled corticosteroids decrease airway inflammation, reducing exacerbations. Pulmonary rehabilitation combines exercise, education, and behavioral changes to enhance physical fitness and quality of life. Coordinated care, including continuous monitoring and integrated care, ensures comprehensive, personalized management, which can reduce hospital readmissions and improve overall patient outcomes. These treatments are crucial for managing COPD symptoms and enhancing patients' quality of life.

Managing chronic obstructive pulmonary disease in the community setting.