CopdMLHCNCT07027852
My Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record
A study testing My Lung Health Coach in people with Copd, run by Women's College Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Copd
- What is being tested?
- My Lung Health Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Be 40 years or older
- Be a current or ex-smoker
- 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
Who cannot join
- 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
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Womens College Hospital
Toronto, Ontario, M5S 1B2
Andrew Kouri, MD, 4163236400, andrew.kouri@wchospital.ca
Andrew Kouri, MD
About this study
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.
Read the 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.
- Conditions
- Copd
- Being tested
- My Lung Health Coach
- Keywords
- COPD, Telehealth, Telemonitoring, Respiratory
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Lung Health CoachBehavioural
Virtual education and self-management program with companion application
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Behavioral | 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. Receives: Behavioral: My Lung Health Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Effectiveness (clinical outcomes): Number of COPD-related outpatient visits
Number of COPD-related outpatient visits
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Effectiveness (clinical outcomes): Medication
Medication
Measured: 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
Measured: 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
Measured: 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
Measured: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Kouri, Women's College Hospital
- Investigators
- Andrew Kouri, MD, Principal investigator, Womens College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027852
- Sponsor's protocol ID
- 1
- Acronym
- MLHC
- Status last verified
- Jun 2025
- First submitted
- 13 Jan 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record
- ClinicalTrials.gov ID
- NCT07027852
- Acronym / sponsor ID
- MLHC / 1
- Conditions
- Copd
- Keywords
- COPD, Telehealth, Telemonitoring, Respiratory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Behavioral | Experimental | Behavioral: My Lung Health CoachStudy 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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Be 40 years or older
Key exclusion criteria (5 listed)
- 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
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Lung Health CoachVirtual education and self-management program with companion application | Behavioural | Single Arm Behavioral |
Primary outcome
Feasibility (system use): Number of patients who started program over total offered, over one year.
Time frame: 1 year
Number of patients who started program over total offered for one year.
Feasibility (system use): Number of patients who completed program over total started, over one year.
Time frame: 1 year
Number of patients who completed program over total started for one year.
Feasibility (system use): Number of providers who referred patients to the program over total Number of providers, over approximately one year.
Time frame: 1 year
Number of providers who referred patients to the program over total Number of providers, over approximately one year.
Effectiveness (clinical outcomes): Number of COPD-related outpatient visits
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Number of COPD-related outpatient visits
Effectiveness (clinical outcomes): Hospital admissions
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Hospital admissions
Effectiveness (clinical outcomes): ED visits
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
ED visits
Effectiveness (clinical outcomes): ICU admissions (at baseline will be over the previous 12 months)
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
ICU admissions (at baseline will be over the previous 12 months)
Effectiveness (clinical outcomes): COPD severity as measured by the COPD assessment test (CAT)
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
COPD severity as measured by the COPD assessment test (CAT)
Effectiveness (clinical outcomes): Medication
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Medication
Effectiveness (clinical outcomes): Referrals: pulmonary rehab
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Referrals: pulmonary rehab
Effectiveness (clinical outcomes): Referrals: smoking cessation counseling
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Referrals: smoking cessation counseling
Effectiveness (clinical outcomes): Referrals: specialist care
Time frame: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.
Referrals: specialist care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Kouri, MD principal investigator
Womens College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Lung Health Coach in people with Copd, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Kouri, MD ((416) 323-6400, andrew.kouri@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (system use): Number of patients who started program over total offered, over one year. (time frame: 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.