CHARM-COPD Program of Care

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Program of Care in Chronic Obstructive Pulmonary Disease Involving Virtual Pulmonary Rehabilitation, Integrated Care and Remote Clinical Monitoring After Discharge From a Recent Exacerbation: Mixed-Methods Study on Feasibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253013
• Other study ID #: 23-5062
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Maryann Calligan, MA
• Phone: 647-381-7024
• Email: maryann.calligan[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Hyfe Smartwatch
Passive recording of audio with detection of explosive sounds. When explosive sounds are detected, a 0.5-1 seconds audio clip is recorded, and run through an algorithm to determine whether or not it is a cough.
• FitBit Versa 2
Commercial watch with the capability to monitor vital signs including oxygen saturation, respiratory rate and heart rate. Patients will be able to view their data in the FitBit app.
• Home Spirometer
Patients will be able to perform spirometry testing at home. They will be able to view their data, and it will be uploaded to a dashboard for clinicians.

Behavioral:
• Audio recording
Patients will be asked to record several sentences which will be analyzed to detect speech patterns that may indicate changes in respiratory conditions.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Salvation Army Toronto Grace Health Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the program and research study	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%).	90 days
Primary	Acceptability by patients and clinicians	Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview	90 days
Primary	Actual usage over 90 days	Actual usage of all program components determined objectively through logs	90 days
Secondary	Readmissions within 30 days	Readmissions to hospital within 30 days of discharge compared to control groups in past studies	30 days