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临床试验/NCT07027852
NCT07027852招募中不适用

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

Women's College Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Feasibility (system use): Number of patients who started program over total offered, over one year.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: My Lung Health Coach (Behavioral)

结局指标

主要结局

Feasibility (system use): Number of patients who started program over total offered, over one year.

时间窗: 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.

时间窗: 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.

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: outcomes will be collected prior to program commencement, at program completion (3 month), and at 6-month follow-up.

Referrals: specialist care

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Kouri

Doctor Andrew Kouri

Women's College Hospital

研究点 (1)

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