Recruiting

CHARM-COPD

Sponsor:

University Health Network, Toronto

Code:

NCT06253013

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Hyfe Smartwatch

FitBit Versa 2

Home Spirometer

Audio recording

Study Details

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT06253013

Start date

Sep 15, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Full study intervention

In addition to the standard of care at the institutions which includes virtual pulmonary rehabilitation, remote clinical monitoring and integrated care, patients will have the option to use the following interventions:

  • FitBit wearable device with continuous monitoring for oxygen saturation and respiratory rate for 90 days
  • Hyfe cough monitoring smartwatch with continuous monitoring for 90 days
  • Home spirometer used once daily for 90 days
  • Audio recordings on a tablet once daily for 90 days

Interventions

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.

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.

Primary outcome measure

  • Feasibility of the program and research study [ Time Frame: 90 days ]
  • Acceptability by patients and clinicians [ Time Frame: 90 days ]
  • Actual usage over 90 days [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Alice Tu, MA

647-381-7024alice.tu2@uhn.ca

Robert Wu, MD

robert.wu@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Principal Investigator:

Robert Wu, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 22, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-22.