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Comprehensive Care Management for COPD (STRIVE Trial)

N/A

Recruiting

Led By Terence Ho, MB, MSc

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

FEV1/FVC<0.7 or radiologic emphysema

>=2 exacerbations of COPD in the last 12-months

Must not have

severe mental illness not controlled by medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to see if teaching healthy behaviours and controlling inflammation can reduce flare-ups of COPD and hospital visits for 1 in 6 Canadians.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial does not specify side effects, interventions may include medications that could cause dry mouth, headaches, or respiratory issues. Comprehensive care might lead to lifestyle changes which generally do not have direct side effects.

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 emphysema or my lung function tests show airflow limitation.

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

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

Exclusion Criteria

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

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My severe mental illness is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Severe exacerbations of COPD

Secondary study objectives

COPD exacerbation associated with inflammation

Change in COPD Assessment Test

Change in Clinical COPD Questionnaire

+20 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: Sputum-guided management and comprehensive care managementExperimental Treatment1 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 CareActive Control1 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.

0 / 4Eligibility criteria met