My Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record (MLHC)

Study Description: My Lung Health Coach (MLHC) is a virtual COPD education and self-management support program delivered through one-on-one sessions with a Certified Respiratory Educator (CRE) over 12 weeks. It includes six sessions that cover essential COPD topics such as: Basic COPD knowledge, Smoking cessation, Medications (inhalers, oxygen), Physical activity, Mental health and wellness, Vaccinations, Symptom self-management, Nutrition, Travel, and Long-term planning (including end-of-life care). 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 on the participants phones, tablets, or desktops. This study will evaluate the feasibility and effectiveness of MLHC and the companion app.

Study Overview

• Status: Recruiting
• Conditions: Copd
• Intervention / Treatment: Behavioral: My Lung Health Coach

Detailed Description

My Lung Health Coach (MLHC) is a freely available evidence-based and person-centered COPD self-management program that connects people virtually with experienced certified respiratory educators (CREs) to provide structured COPD education and self-management support. MLHC was jointly developed by the Lung Health Foundation (a charitable organization focused on lung health advocacy) and academic Respirologist Dr. Andrew Kouri, with input from community members living with COPD. MLHC links community members living with COPD with certified respiratory health educators, using a person-centred approach to provide COPD education and self-management support. It is delivered virtually through one-on-one meetings offered over multiple sessions over 12 weeks. The topics covered in the program include: general COPD knowledge, smoking cessation, COPD medications (inhalers, oxygen), physical activity counselling, mental health and wellness, vaccinations, symptom self-management skills (breathing, energy management, symptom monitoring), nutrition, travel, and long-term planning (including end-of-life care).

To improve the patient experience using MLHC, the investigators have integrated the MLHC program into the Epic Care Companion app at Women's College Hospital, an interactive patient-facing app designed as an extension of the Epic electronic health record system. Using Care Companion, patients will be able to track their progress through MLHC, accomplish session-specific educational and self-management tasks, and share their progress with their Women's College healthcare teams.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Kouri, MD; Phone Number: (416) 323-6400; Email: andrew.kouri@wchospital.ca
• Study Contact Backup: Name: kinza ahmed, Bsc; Phone Number: 6478941963; Email: kinza.ahmed@wchospital.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Recruiting
      • Womens College Hospital
      • Contact: Andrew Kouri, MD; Phone Number: 4163236400; Email: andrew.kouri@wchospital.ca
      • Principal Investigator: Andrew Kouri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be deemed to have capacity to provide informed consent;
2. Must sign and date the informed consent form;
3. Stated willingness to comply with all study procedures;
4. Be diagnosed with COPD as per a WCH Respirologist
5. Be 40 years or older
6. Be a current or ex-smoker
7. Preferred but not required: have a history of at least 1 COPD exacerbation (requiring prednisone or antibiotic use, or an urgent healthcare visit of any kind) in the previous 12 months

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm Behavioral; 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.

Behavioral: My Lung Health Coach; Virtual education and self-management program with companion application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (system use): Number of patients who started program over total offered, over one year.	Number of patients who started program over total offered for one year.	1 year
Feasibility (system use): Number of patients who completed program over total started, over one year.	Number of patients who completed program over total started for one year.	1 year
Feasibility (system use): Number of providers who referred patients to the program over total Number of providers, over approximately one year.	Number of providers who referred patients to the program over total Number of providers, over approximately one year.	1 year
Effectiveness (clinical outcomes): Number of COPD-related outpatient visits	Number of COPD-related outpatient visits	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Hospital admissions	Hospital admissions	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): ED visits	ED visits	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): ICU admissions (at baseline will be over the previous 12 months)	ICU admissions (at baseline will be over the previous 12 months)	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): COPD severity as measured by the COPD assessment test (CAT)	COPD severity as measured by the COPD assessment test (CAT)	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Medication	Medication	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Referrals: pulmonary rehab	Referrals: pulmonary rehab	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Referrals: smoking cessation counseling	Referrals: smoking cessation counseling	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Referrals: specialist care	Referrals: specialist care	outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Investigators: Principal Investigator: Andrew Kouri, MD, Womens College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: June 16, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Telemonitoring; Telehealth; Respiratory
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No