Comprehensive Care Management for COPD

(STRIVE Trial)

Recruiting at 1 trial location

Overseen By Terence N Ho, MB, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Severe mental illness, life-expectancy

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce flare-ups in people with chronic obstructive pulmonary disease (COPD), a common lung condition without a cure. Researchers will test whether teaching patients better self-care and using personalized medication plans based on sputum (phlegm) analysis—known as sputum-guided management and comprehensive care management—leads to fewer hospital visits compared to standard care. Participants may be a good fit if they have experienced two or more COPD flare-ups in the past year and have a history of significant smoking. As an unphased trial, this study offers a unique opportunity to contribute to innovative COPD care strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems the focus is on ensuring you are on the right medicines, so you may need to adjust your medications based on the trial's guidance.

What prior data suggests that this comprehensive care management and sputum-guided management is safe for COPD patients?

Research has shown that sputum-guided treatment combined with comprehensive care for COPD is generally well-received by patients. One study found that this method led to nearly a 75% reduction in COPD flare-ups. Although specific safety details are not highlighted, the significant decrease in flare-ups suggests that patients manage the treatment well. If the treatment caused issues, more flare-ups would be expected, not fewer. This indicates a positive safety profile, even without detailed safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comprehensive care management for COPD because it integrates sputum-guided management with personalized care. Unlike standard COPD treatments that often focus solely on medication and symptom management, this approach uses sputum biomarkers to tailor treatment specifically to an individual's airway inflammation. This personalized method could potentially improve flare-up management by customizing interventions based on real-time inflammation data, offering a more targeted approach to care. Additionally, the comprehensive care model includes self-management education and resource coordination, which might enhance patient outcomes by empowering patients and ensuring consistent support across hospital and community settings.

What evidence suggests that sputum-guided management and comprehensive care management could be effective for COPD?

Research has shown that sputum-guided management combined with comprehensive care can greatly reduce COPD flare-ups. In this trial, participants in the experimental arm will receive this combined approach. Studies have demonstrated that it leads to nearly a 75% reduction in hospital visits related to COPD after discharge. This method uses a patient's sputum (mucus from the lungs) to select the appropriate medicines for controlling lung inflammation. Educating patients on managing COPD and coordinating their care are also crucial components of this strategy. These findings suggest that this treatment could help many people with COPD experience fewer flare-ups. ^{1 2 3 4 6}

Who Is on the Research Team?

Terence Ho, MB MSc

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

This trial is for individuals with COPD who have had at least two flare-ups in the past year and a significant history of smoking. They must show specific lung function test results or signs of emphysema on imaging. People with severe uncontrolled mental illness or those not expected to live more than six months cannot participate.

Inclusion Criteria

I have been diagnosed with emphysema or my lung function tests show airflow limitation.

I have had 2 or more COPD flare-ups in the past year.

I have smoked more than 10 packs of cigarettes a year.

Exclusion Criteria

My severe mental illness is not controlled by medication.

You are not expected to live for more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Treatment

Participants receive comprehensive care management and sputum biomarker-directed treatment of airway inflammation

6 months

Clinic visits at 2, 6, and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sputum-guided management and comprehensive care management

Trial Overview The study compares sputum-guided management combined with comprehensive care against usual care for COPD patients. It aims to see if personalized education, behavior support, and tailored medication based on phlegm analysis can reduce hospital visits due to flare-ups.

How Is the Trial Designed?

Group I: Sputum-guided management and comprehensive care management Experimental Treatment 1 Intervention

The intervention consists of 6-months of CCM and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits at 2, 6, and 16 weeks. The key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Clinic nurse will review inhaler technique with the patient. Sputum (spontaneous) biomarkers will be measured with results used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge, at both sites.

Group II: Usual Care Active Control 1 Intervention

This group will also receive clinic visits at 2, 6, and 16 weeks with a study physician, and also education material, inhaler technique assessment and education, and case management from the clinic personnel. The study physician will pursue further investigation and/or further intervention if they see fit.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton Academic Health Sciences Organization

Collaborator

Trials

22

Recruited

5,200+

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Published Research Related to This Trial

Chronic obstructive pulmonary disease (COPD) is a major health issue, being the fourth leading cause of death, yet its treatment is often underutilized and focuses mainly on acute care rather than long-term management.

The chronic care model (CCM) offers a proactive approach to managing COPD by emphasizing self-management, community resources, and evidence-based guidelines, which can improve patient outcomes and shift care from reactive to preventive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated management strategies for chronic obstructive pulmonary disease. Sonetti, DA., Hospenthal, AC., Adams, SG.[2021]

A study of 542 COPD patients in France revealed significant discrepancies between actual treatment practices and GOLD guidelines, with 11% of severe COPD patients not receiving necessary bronchodilators.

Inhaled corticosteroids (ICS) were overprescribed in mild COPD stages, while essential interventions like influenza vaccination and pulmonary rehabilitation were underutilized, highlighting gaps in guideline adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COPD routine management in France: are guidelines used in clinical practice?]. Jebrak, G.[2022]

In a study of 134 patients admitted for COPD exacerbations, adherence to the COPD-X Plan was high for essential diagnostics like chest radiographs (97%) and electrocardiograms (94%), indicating good initial management practices.

However, there were significant gaps in care, such as inadequate use of arterial blood gases, excessive supplemental oxygen, and low rates of referrals for pulmonary rehabilitation, highlighting the need for improved adherence to guidelines in managing COPD exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalised exacerbations of chronic obstructive pulmonary disease: adherence to guideline recommendations in an Australian teaching hospital. Sha, J., Worsnop, CJ., Leaver, BA., et al.[2021]

Chronic disease management programs for patients with COPD were found to improve quality of life, with 5 out of 10 randomized-controlled trials showing significant positive outcomes.

The studies varied widely in their methods and quality, indicating a need for more comprehensive research to better understand the effectiveness of these programs across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease. Niesink, A., Trappenburg, JC., de Weert-van Oene, GH., et al.[2019]

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]

A systematic review of 25 trials found that chronic disease management (CDM) programs for COPD do not significantly affect mortality rates, with a pooled odds ratio of 1.00, indicating no increased risk.

The study suggests that CDM programs do not expose COPD patients to higher mortality risks, providing reassurance about their safety in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality of patients with COPD participating in chronic disease management programmes: a happy end? Peytremann-Bridevaux, I., Taffe, P., Burnand, B., et al.[2018]

In a study analyzing 36,893 COPD patients, only 23% were eligible for participation in 31 randomized controlled trials (RCTs) of inhaled long-acting bronchodilator therapy, indicating a significant gap between trial populations and real-world patients.

The findings suggest that while RCT participants may be more representative of the general COPD population than previously thought, specific eligibility criteria, such as requiring a history of exacerbations, can drastically reduce the number of eligible patients, highlighting the need for careful interpretation of RCT results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy. Halpin, DM., Kerkhof, M., Soriano, JB., et al.[2019]

Spirometry is essential for diagnosing and staging COPD before starting treatment, ensuring that patients receive appropriate care based on their condition.

Effective management of mild to moderate COPD, which affects 95% of patients, typically involves the use of long-acting bronchodilators, which can significantly improve symptoms, exercise capacity, and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care of the patient with chronic obstructive pulmonary disease-part 2: pharmacologic treatment across all stages of disease. Gross, N., Levin, D.[2008]

In a study involving 1,202 patients with chronic obstructive pulmonary disease (COPD), adding disease management (DM) to recommended care (RC) did not significantly improve outcomes, such as delaying hospital admissions or death.

The results showed that both groups had similar rates of primary endpoint events, indicating that the additional DM intervention did not provide a clear benefit over standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease Management plus Recommended Care versus Recommended Care Alone for Ambulatory Patients with Chronic Obstructive Pulmonary Disease. Kalter-Leibovici, O., Benderly, M., Freedman, LS., et al.[2021]

The Remote-Management of COPD trial aims to evaluate a digital service model for high-risk COPD patients, focusing on improving self-management and integrated care, with a duration of 2 years and starting in September 2019.

This study will assess the feasibility and clinical impact of the digital approach compared to standard care, potentially using machine learning to predict exacerbations and outcomes, which could enhance COPD management significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care (RECEIVER): the protocol for a feasibility and service adoption observational cohort study. Taylor, A., Lowe, DJ., McDowell, G., et al.[2021]

A study involving 191 previously hospitalized COPD patients found that a self-management education program, 'Living Well with COPD,' combined with usual care, initially costs more per patient than standard care but has the potential to be cost-effective with higher patient caseloads.

If case managers can effectively supervise 50 patients, the self-management program could save $2,149 per patient, suggesting that increasing the number of patients managed could lead to significant economic benefits and reduced hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic benefits of self-management education in COPD. Bourbeau, J., Collet, JP., Schwartzman, K., et al.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04890938

Sputum-guided Treatment With Comprehensive Care ... Experimental : Sputum-guided management and comprehensive care management. The intervention consists of 6-months of CCM and sputum biomarker-directed treatment ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34223776/

Comprehensive Care Management in Conjunction with ... A COPD post-discharge clinic combining sputum-guided treatment and CCM was feasible and associated with a nearly 75% reduction in the incidence ...

3. trialx.com trialx.com/clinical-trials/listings/264201/sputum-guided-treatment-with-comprehensive-care-management-in-copd-a-randomized-controlled-trial/?&radius=50

Sputum-guided Treatment With Comprehensive Care ... The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right ...

4. withpower.com withpower.com/trial/phase-3-10-2021-21c42

Comprehensive Care Management for COPD (STRIVE Trial) Chronic disease management programs for patients with COPD were found to improve quality of life, with 5 out of 10 randomized-controlled trials showing ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/15412555.2021.1945022

Full article: Comprehensive Care Management in ... A COPD post-discharge clinic combining sputum-guided treatment and CCM was feasible and associated with a nearly 75% reduction in the incidence of COPD-related ...

6. emedicine.medscape.com emedicine.medscape.com/article/297664-treatment

Chronic Obstructive Pulmonary Disease (COPD) Treatment ... Results demonstrated the long-term efficacy (eg, improved FEV1 at 0-3 hr and trough FEV1) and safety of once-daily olodaterol 5 mcg in patients ...