Clinical trial NCT04890938: Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial
Official title: Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: COPD
Exacerbation
Comprehensive care management
Sputum
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
name: St. Joseph's Healthcare Hamilton
name: Hamilton Health Sciences Corporation
First posted: 2021-05-18
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* \>=2 exacerbations of COPD in the last 12-months, FEV1/FVC\<0.7 or radiologic emphysema, with a \>-10 pack-year smoking history

Exclusion Criteria:

* severe mental illness not controlled by medication or life-expectancy less than 6-months

Primary outcomes:
measure: Severe exacerbations of COPD
timeFrame: 6 months
Secondary outcomes:
measure: Moderate COPD Exacerbation
timeFrame: 6 months
measure: Mild COPD Exacerbation
timeFrame: 6 months
measure: COPD exacerbation associated with inflammation
timeFrame: 6 months
measure: Time to first COPD exacerbation associated with inflammation
timeFrame: 6 months
measure: Time to first COPD exacerbation
timeFrame: 6 months
measure: Change in Clinical COPD Questionnaire
timeFrame: 26 weeks
measure: Change in COPD Assessment Test
timeFrame: 26 weeks
measure: Change in Patient Health Questionnaire-9
timeFrame: 26 weeks
measure: Change in General Anxiety Disorder-7 questionnaire
timeFrame: 26 weeks
measure: EQ-5D-5L questionnaire
timeFrame: 26 weeks
measure: FEV1
timeFrame: 16 weeks
measure: Sputum eosinophil percentage
timeFrame: 16 weeks
measure: Sputum neutrophil count
timeFrame: 16 weeks
measure: Sputum abnormalities rectified
timeFrame: 16 weeks
measure: Use of oral or inhaled corticosteroid
timeFrame: 6 months
measure: Use of antibiotics
timeFrame: 6 months
measure: Participant recruitment number
timeFrame: 2 years
measure: Reason for non-participation
timeFrame: 2 years
measure: Clinic attendance
timeFrame: 6 months
measure: Number of days to visit 1
timeFrame: Should fall within a 2-3 week window
measure: Number of clinic visits
timeFrame: 6 months
measure: Patient care
timeFrame: study duration
measure: Side effects
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Terence Ho, MB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nici L, ZuWallack R. Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. COPD. 2018 Jun;15(3):223-230. doi: 10.1080/15412555.2018.1501671. Epub 2018 Sep 5.
citation: Bourbeau J, Bhutani M, Hernandez P, Marciniuk DD, Aaron SD, Balter M, et al. CTS position statement: Pharmacotherapy in patients with COPD-An update. Canadian Journal of Respiratory, Critical Care, and Sleep Medicine. 2017;1(4):222-41.
citation: Wilson AM, Nair P, Hargreave FE, Efthimiadis AE, Anvari M, Allen CJ; ELVIS Research Study Group. Lipid and smoker's inclusions in sputum macrophages in patients with airway diseases. Respir Med. 2011 Nov;105(11):1691-5. doi: 10.1016/j.rmed.2011.07.011. Epub 2011 Aug 9.
citation: Leigh R, Sharon RF, Efthimiadis A, Hargreave FE, Kitching AD. Diagnosis of left-ventricular dysfunction from induced sputum examination. Lancet. 1999 Sep 4;354(9181):833-4. doi: 10.1016/S0140-6736(99)80018-X.