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

NCT07027852 | Recruiting

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Copd

Keywords

COPD; Telehealth; Telemonitoring; Respiratory

Outcome Measures

Primary Outcomes (12)

• 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.

Study Arms (1)

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.

Behavioral: My Lung Health Coach

Interventions

My Lung Health Coach BEHAVIORAL

Virtual education and self-management program with companion application

Single Arm Behavioral

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Womens College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Kouri, MD

  Womens College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kouri, MD

CONTACT

(416) 323-6400; andrew.kouri@wchospital.ca

kinza ahmed, Bsc

CONTACT

6478941963; kinza.ahmed@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Andrew Kouri

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: June 19, 2025
• Study Start: January 15, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 5, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CA (1)