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Behavioral Intervention
Program of Care for COPD
N/A
Recruiting
Led By Robert Wu, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
Significant cognitive impairment and absence/inability of a family caregiver to consent and to follow study processes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a program for COPD patients. The program includes online exercises, coordinated care from different healthcare providers, and remote health monitoring to help them stay healthy at home.
Who is the study for?
This trial is for patients with COPD who were recently discharged after a severe flare-up and referred to Virtual Pulmonary Rehabilitation or Remote Clinical Monitoring at Toronto Grace Health Centre. It's not for those with other major lung diseases, very short life expectancy, or significant cognitive issues without caregiver support.
What is being tested?
The CHARM-COPD program includes virtual pulmonary rehabilitation, integrated care, and remote monitoring using tools like the Hyfe Smartwatch, Home Spirometer, FitBit Versa 2, and audio recording to manage COPD after hospital discharge.
What are the potential side effects?
Since this trial involves non-invasive monitoring devices and virtual programs rather than medications, typical drug side effects are not expected. However, participants may experience discomfort or inconvenience from wearing devices.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My main lung problem is not COPD, but another condition like asthma.
Select...
I have severe memory or thinking problems and no family caregiver to help with study requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability by patients and clinicians
Actual usage over 90 days
Feasibility of the program and research study
Secondary study objectives
Readmissions within 30 days
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Full study interventionExperimental Treatment4 Interventions
In addition to the standard of care at the institutions which includes virtual pulmonary rehabilitation, remote clinical monitoring and integrated care, patients will have the option to use the following interventions:
* FitBit wearable device with continuous monitoring for oxygen saturation and respiratory rate for 90 days
* Hyfe cough monitoring smartwatch with continuous monitoring for 90 days
* Home spirometer used once daily for 90 days
* Audio recordings on a tablet once daily for 90 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Audio recording
2020
Completed Phase 1
~130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, pulmonary rehabilitation, and coordinated care. Bronchodilators relax the airway muscles, improving airflow and reducing breathlessness.
Inhaled corticosteroids decrease airway inflammation, reducing exacerbations. Pulmonary rehabilitation combines exercise, education, and behavioral changes to enhance physical fitness and quality of life.
Coordinated care, including continuous monitoring and integrated care, ensures comprehensive, personalized management, which can reduce hospital readmissions and improve overall patient outcomes. These treatments are crucial for managing COPD symptoms and enhancing patients' quality of life.
Managing chronic obstructive pulmonary disease in the community setting.
Managing chronic obstructive pulmonary disease in the community setting.
Find a Location
Who is running the clinical trial?
University of TorontoOTHER
725 Previous Clinical Trials
1,115,592 Total Patients Enrolled
The Salvation Army Toronto Grace Health CentreUNKNOWN
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,222 Total Patients Enrolled
Robert Wu, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
50 Total Patients Enrolled