Program of Care for COPD

Overseen By Alice Tu, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Bronchiectasis, Asthma, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new care program for people with COPD, a lung disease that makes breathing difficult, especially after a flare-up. The CHARM-COPD Program of Care includes virtual rehab, remote health monitoring, and integrated care, featuring tools like a Fitbit, a cough-monitoring smartwatch, and a home spirometer (a device to measure lung function). The study aims to assess the program's practicality and user-friendliness for patients. Individuals discharged from a hospital after a COPD flare-up and referred to certain care programs might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions for COPD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program of care is safe for COPD patients?

Research has shown that the CHARM-COPD Program of Care emphasizes online lung health exercises, coordinated care, and remote health check-ups for individuals with COPD (chronic obstructive pulmonary disease). Although specific safety data from past studies is lacking, similar health programs generally receive positive feedback. Online exercises and remote check-ups are common in COPD management and have not been linked to major safety issues.

The program employs devices such as a FitBit to track oxygen levels and breathing rates, a smartwatch to monitor coughing, and a home device for daily lung function checks. These non-invasive tools carry minimal risk and are widely used in various health settings, indicating their safety for most people. Overall, available evidence supports the likelihood that the CHARM-COPD Program of Care is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHARM-COPD Program of Care because it integrates innovative technology with standard treatments for COPD. Unlike traditional care that often relies on medications and occasional in-person check-ups, this program utilizes continuous monitoring devices such as a FitBit for tracking oxygen saturation and respiratory rate, and a Hyfe cough monitoring smartwatch. These tools offer real-time data and insights, potentially leading to more personalized and timely interventions. Additionally, the use of a home spirometer and daily audio recordings empowers patients to actively participate in their own care, making it a truly comprehensive approach to managing COPD.

What evidence suggests that this program of care is effective for COPD?

Research shows that programs designed to manage COPD yield promising results. They help people walk about 32 meters farther and reduce the likelihood of hospitalization. The CHARM-COPD Program of Care, provided to participants in this trial, includes online lung health exercises, coordinated care, and remote check-ups, simplifying condition management. Another study found fewer emergency room visits, indicating improved management. Overall, these methods enhance quality of life for people with COPD and help keep them out of the hospital. ^{1 4 6 7 8}

Who Is on the Research Team?

Robert Wu, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was referred for virtual lung rehab or remote monitoring after leaving the hospital for a severe lung flare-up.

Exclusion Criteria

Projected life expectancy ≤ 2 months, as determined by the clinical team

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual pulmonary rehabilitation, integrated care, and remote clinical monitoring, including the use of a FitBit, Hyfe cough monitoring smartwatch, home spirometer, and audio recordings for 90 days

12 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on readmissions within 30 days

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHARM-COPD Program of Care

Trial Overview

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.

How Is the Trial Designed?

Group I: Full study intervention Experimental Treatment 4 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

The Salvation Army Toronto Grace Health Centre

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

The study analyzed a COPD patient register of 4257 cases and found that long-acting bronchodilator treatments significantly reduced exacerbations in COPD patients, highlighting their efficacy in managing the disease.

Vaccination with the PCV13 pneumococcal vaccine was shown to decrease the frequency of exacerbations and severity of dyspnea, suggesting an important role for vaccination in the overall management of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease patients electronic register analysis: the effectiveness of patient's dynamic follow up and evaluation of treatment program. Mishlanov, VJ., Shubin, IV., Bekker, KN., et al.[2019]

The implementation of a COPD nurse navigator program significantly reduced emergency department visits and hospitalizations related to respiratory issues among 202 patients, indicating improved patient management.

The program not only enhanced patient outcomes but also resulted in estimated annual savings of over $260,000, demonstrating its cost-effectiveness in managing chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated interdisciplinary care for patients with chronic obstructive pulmonary disease reduces emergency department visits, admissions and costs: a quality assurance study. Dajczman, E., Robitaille, C., Ernst, P., et al.[2021]

In a study involving 191 patients with asthma and COPD, an additional nursing care program did not significantly improve knowledge, inhalation technique, self-management, or quality of life compared to standard care.

However, the program did lead to a significant reduction in exacerbation rates, with an odds ratio of 0.35, indicating that patients receiving the additional care experienced fewer severe episodes of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial. Rootmensen, GN., van Keimpema, AR., Looysen, EE., et al.[2019]

A comprehensive COPD care program developed in a rural community in Western Canada from 2012 to 2021 successfully improved access and quality of care through team-based approaches and local resource integration, as evaluated through stakeholder interviews and document reviews.

Key innovations included securing physician compensation and enhancing patient and provider self-efficacy, which built the capacity of the healthcare system and emphasized the importance of relationships and collaboration in delivering effective rural healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of the Rural and Northern Community Focused Model of COPD Care (RaNCoM). Freeman, S., Peach, L., Ross, C., et al.[2023]

Disease-management programs for COPD significantly improved exercise capacity by an average of 32.2 meters and reduced the risk of hospitalization, indicating their effectiveness in enhancing patient care.

While these programs improved health-related quality of life, they did not have a significant impact on all-cause mortality, suggesting that while they are beneficial, they may not reduce overall death rates in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Peytremann-Bridevaux, I., Staeger, P., Bridevaux, PO., et al.[2018]

The integrated management program (I1) for COPD patients led to a significant reduction in smoking rates and a decrease in exacerbations compared to the isolated intervention (I2), indicating its effectiveness in managing the disease over a follow-up period of 31.2 months.

While lung function and quality of life did not show significant changes in either group, the correct use of inhalers improved, suggesting that both management strategies can enhance patient adherence to treatment, which is crucial for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is the introduction of clinical management programs for patients with chronic obstructive pulmonary disease useful? Comparison of the effectiveness of two interventions on the clinical progress and care received]. Solanes, I., Bolíbar, I., Llauger, MA., et al.[2019]

Current COPD patient education programs have shown limited success, indicating a need for more effective designs that go beyond just providing medical information.

Future programs should focus on improving patients' self-efficacy in disease management and include a broader range of health behavior determinants to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education programs--can they improve outcomes in COPD? Harris, M., Smith, BJ., Veale, A.[2021]

A comprehensive care program for patients recently discharged after an acute exacerbation of COPD significantly reduced hospital readmission rates by 33.2% compared to usual care over 12 months.

Patients in the comprehensive care group also experienced a shorter length of hospital stay and improved symptoms, as indicated by better scores on the Modified Medical Research Council Dyspnoea Scale and the St George's Respiratory Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Ko, FW., Cheung, NK., Rainer, TH., et al.[2022]

The COPDnet integrated care model significantly improved health status in patients with COPD, as measured by the Clinical COPD Questionnaire, with scores decreasing from 1.94 to 1.73 over 7-9 months in 154 patients.

The most notable improvements were seen in patients who participated in interdisciplinary pulmonary rehabilitation, while those receiving only pharmacotherapy or other forms of care did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the COPDnet integrated care model. Koolen, EH., van den Borst, B., de Man, M., et al.[2021]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

The Copenhagen Hospital Corporation successfully implemented a reporting system for adverse events, resulting in 6011 reported incidents over three years, indicating a strong safety culture among staff.

The organization conducted 92 root cause analyses during this period, focusing on both optional and mandatory reports, which highlights their commitment to understanding and preventing future adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. Rabøl, LI., Jensen, EB., Hellebek, AH., et al.[2006]

A multifaceted program implemented in a respiratory ICU significantly reduced adverse events, including accidental extubation, pneumothorax, and atelectasis, among 1662 patients over a 7-year period.

The program's components, which included strategic planning, training on hand hygiene, and care bundles, also led to a decrease in ICU mortality, demonstrating the efficacy of comprehensive interventions in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of strategic planning, organizational culture imprint and care bundles to reduce adverse events in the ICU. Álvarez-Maldonado, P., Reding-Bernal, A., Hernández-Solís, A., et al.[2020]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

Out of 1,244 reported adverse drug events, 208 were medication-related, with anticoagulants being the most frequently implicated class (46% of events), highlighting a significant area for safety improvement in ambulatory care.

Key recommendations for reducing harm include better follow-up on anticoagulant therapy, improved prescribing practices for antibiotics, enhanced patient education for hypoglycemics, and alerts to prevent dangerous drug interactions between opioids and benzodiazepines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adverse events in the ambulatory setting: A mixed-methods analysis. Wong, J., Lee, SY., Sarkar, U., et al.[2022]

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