Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial
- Conditions
- COPD
- Interventions
- Combination Product: Sputum-guided management and comprehensive care managementOther: Usual Care
- Registration Number
- NCT04890938
- Lead Sponsor
- McMaster University
- Brief Summary
Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem.
Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical 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 medicines will have fewer COPD flare-ups than those who get normal care.
- Detailed Description
STRIVE is a randomized-controlled trial comparing a two-pronged intervention, including sputum-biomarker-directed treatment of airway inflammation, and comprehensive care management, to usual care, for COPD patients with frequent exacerbation from two sites.
The intervention consists of 6-months of comprehensive care management (CCM) and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits will occur at 2, 6 and 16 weeks after hospital discharge. For the intervention group, the key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Spontaneous sputum biomarkers will be used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- >=2 exacerbations of COPD in the last 12-months, FEV1/FVC<0.7 or radiologic emphysema, with a >-10 pack-year smoking history
- severe mental illness not controlled by medication or life-expectancy less than 6-months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sputum-guided management and comprehensive care management Sputum-guided management and comprehensive care management 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. Usual Care Usual Care 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.
- Primary Outcome Measures
Name Time Method Severe exacerbations of COPD 6 months As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.
- Secondary Outcome Measures
Name Time Method Sputum eosinophil percentage 16 weeks Change in sputum eosinophil percentage between clinic visits 1 and 3
Sputum neutrophil count 16 weeks Change in sputum neutrophil count between clinic visits 1 and 3
Reason for non-participation 2 years reasons for non-participation during recruitment period
Change in Clinical COPD Questionnaire 26 weeks Change in Clinical COPD Questionnaire between Week 0 and Week 26.
Patient care study duration number of nursing telephone calls initiated by the patient, number of adequate sputum samples collected, and the number referred to a smoking cessation program
FEV1 16 weeks Change in FEV1 between clinic visits 1 and 3.
Sputum abnormalities rectified 16 weeks The number of subjects who have their sputum abnormalities rectified will be recorded between clinics 1 and 3
Time to first COPD exacerbation 6 months Defined as time to an exacerbation (as defined previously)
Change in Patient Health Questionnaire-9 26 weeks Change in Patient Health Questionnaire-9 between Week 0 and Week 26.
Change in COPD Assessment Test 26 weeks Change in COPD Assessment Test between Week 0 and Week 26.
Use of antibiotics 6 months Cumulative courses of oral or intravenous antibiotics
Number of days to visit 1 Should fall within a 2-3 week window number of days to visit 1 from hospital discharge
EQ-5D-5L questionnaire 26 weeks Change in EQ-5D-5L between Week 0 and Week 26.
Moderate COPD Exacerbation 6 months as defined by worsening of symptoms requiring the use of antibiotics or steroids without ER visit or hospitalization
Mild COPD Exacerbation 6 months Defined as worsening of symptoms that were self-managed and resolved without systemic steroids or antibiotics; captured by Clinical COPD Questionnaire
COPD exacerbation associated with inflammation 6 months Defined as an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture
Time to first COPD exacerbation associated with inflammation 6 months Defined as time to an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture
Use of oral or inhaled corticosteroid 6 months Cumulative dose of oral and inhaled corticosteroid
Change in General Anxiety Disorder-7 questionnaire 26 weeks Change in General Anxiety Disorder-7 questionnaire between Week 0 and Week 26.
Number of clinic visits 6 months Number of clinic visits patients attend during the 6 months that they are participating in the study
Side effects 26 weeks Side effects will be captured by noting peak serum glucose levels and blood pressure measured in-hospital, and the occurrence of psychosis, candidiasis, C. difficile infection, and gastrointestinal upset as reported by the patient during clinic visits
Participant recruitment number 2 years number of patients approached for recruitment during study
Clinic attendance 6 months Number of clinic visits attended while enrolled in the study
Trial Locations
- Locations (2)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada