Skip to content

CHARM-COPD Program of Care

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06253013
Enrollment
100
Registered
2024-02-12
Start date
2023-09-15
Completion date
2027-06-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Remote Clinical Monitoring, COPD, Wearables, Digital Health, Self-management

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.

Interventions

DEVICEHyfe 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.

DEVICEFitBit 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.

DEVICEHome 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.

BEHAVIORALAudio recording

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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER
The Salvation Army Toronto Grace Health Centre
CollaboratorUNKNOWN
University of Toronto
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the program and research study90 daysFeasibility 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%).
Acceptability by patients and clinicians90 daysAcceptability of the program as determined by patient questionnaire as well as patient and health care provider interview
Actual usage over 90 days90 daysActual usage of all program components determined objectively through logs

Secondary

MeasureTime frameDescription
Readmissions within 30 days30 daysReadmissions to hospital within 30 days of discharge compared to control groups in past studies

Countries

Canada

Contacts

CONTACTAlice Tu, MA
alice.tu2@uhn.ca647-381-7024
CONTACTRobert Wu, MD
robert.wu@uhn.ca
PRINCIPAL_INVESTIGATORRobert Wu, MD

University Health Network, Toronto

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026