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MLHC

Virtual COPD Self-management Program with Integrated Patient Record

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Study AimThis study evaluates the feasibility and effectiveness of a virtual COPD self-management program with integrated patient record. It aims to measure system use, clinical outcomes such as hospital visits and medication, and referrals to support services.
What is being tested

My Lung Health Coach

Behavioral
Who is being recruted

Copd

From 40 to 100 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2025

See protocol details

Summary

Principal SponsorWomen's College Hospital
Study ContactAndrew Kouri, MD
Last updated: June 19, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 15, 2025Actual date on which the first participant was enrolled.

This study focuses on a program called My Lung Health Coach (MLHC) designed to support people with chronic obstructive pulmonary disease (COPD) in managing their condition. The program is virtual, meaning participants connect online with certified respiratory educators for personalized education and support. It aims to provide individuals with the tools and knowledge needed to manage their COPD better, including advice on medications, physical activity, mental health, and more. This kind of support can help improve the quality of life for those living with COPD by offering guidance and resources that are often difficult to access. Participants in the study will engage in this program through the Epic Care Companion app, allowing them to track their progress and manage their health more effectively. The program lasts for 12 weeks, during which participants have multiple sessions with health educators. These sessions cover various aspects of COPD management, including breathing techniques and symptom monitoring. The integration with the app helps participants stay organized and communicate easily with their healthcare team, potentially leading to better health outcomes.

Official TitleMy Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record 
Principal SponsorWomen's College Hospital
Study ContactAndrew Kouri, MD
Last updated: June 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 40 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Copd
Criteria
7 inclusion criteria required to participate
Must be deemed to have capacity to provide informed consent
Must sign and date the informed consent form
Stated willingness to comply with all study procedures
Be diagnosed with COPD as per a WCH Respirologist

Show More Criteria

5 exclusion criteria prevent from participating
Experienced a COPD exacerbation in the 4 previous weeks to study enrollment
Co-diagnosis of asthma by a WCH Respirologist
Significant co-morbidities that could interfere with program participation or terminal illness
Unwilling to download and use the Epic Care Companion app and has a unsuitable mobile device to do this

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Description: My Lung Health Coach (MLHC) is a virtual COPD education and self-management support program delivered by a Certified Respiratory Educator (CRE) over 12 weeks. The investigators have also developed a companion app to MLHC integrated into the electronic patient record that patients can access through their EPIC MyHealth app. This study will evaluate the feasibility and effectiveness of MLHC and the companion app.
Study Objectives
Primary Objectives

Number of patients who started program over total offered for one year.

Number of patients who completed program over total started for one year.

Number of providers who referred patients to the program over total Number of providers, over approximately one year.

Number of COPD-related outpatient visits

Hospital admissions

ED visits

ICU admissions (at baseline will be over the previous 12 months)

COPD severity as measured by the COPD assessment test (CAT)

Medication

Referrals: pulmonary rehab

Referrals: smoking cessation counseling

Referrals: specialist care

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Womens College HospitalToronto, CanadaSee the location
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One Study Center