CHARM-COPD Program of Care

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06253013
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The investigators' goal for this project is to evaluate the feasibility, acceptability, and actual usage of a program of care for patients with COPD recently discharged after an acute exacerbation. The program of care includes virtual pulmonary rehabilitation, integrated care, and remote clinical monitoring.

Detailed Description

The investigators' goal for this project is to evaluate the feasibility, acceptability, and actual usage of a multimodal, individualized program of care for patients with COPD recently discharged from hospital with an acute exacerbation. The program will combine elements of existing standards of care at two institutions, Toronto Grace Health Centre and University Health Network, with emerging technologies.

The investigators want to determine whether the program is considered appropriate and useful to both patients and health care providers, and whether it is feasible to implement. The investigators also want to determine whether it is feasible to conduct a large-scale randomized control trial of the program. The investigators will also explore whether each intervention reduces re-admissions to hospital.

Study Timeline

• Study Start: 2023-09-15
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Referred to either Virtual Pulmonary Rehabilitation or Remote Clinical Monitoring at Toronto Grace Health Centre after discharge from UHN hospital with an AECOPD as defined by the clinical team

Exclusion Criteria

• Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
• Projected life expectancy ≤ 2 months , as determined by the clinical team
• Significant cognitive impairment and absence/inability of a family caregiver to consent and to follow study processes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the program and research study	90 days	Feasibility of the study and the program of care as determined by study participation and completion. The primary endpoints will be enrollments per month (at least 3 per study site) and data and follow up completeness (at least 75%).
Actual usage over 90 days	90 days	Actual usage of all program components determined objectively through logs
Acceptability by patients and clinicians	90 days	Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview

Secondary Outcome Measures

Name	Time	Method
Readmissions within 30 days	30 days	Readmissions to hospital within 30 days of discharge compared to control groups in past studies

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada