Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

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

Locations
Other Locations
Canada
Hamilton General Hospital
NOT_YET_RECRUITING
Hamilton
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Contact Information
Primary
Terence N Ho, MB, MSc
hot4@mcmaster.ca
9055221155
Backup
Joshua Wald, MD
joshua.wald@medportal.ca
9055221155
Time Frame
Start Date: 2022-05-27
Estimated Completion Date: 2025-08
Participants
Target number of participants: 128
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Collaborators: Hamilton Academic Health Sciences Organization, Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
Leads: McMaster University

This content was sourced from clinicaltrials.gov