Chronic Obstructive Pulmonary DiseaseNCT06253013
CHARM-COPD Program of Care
A study testing Hyfe Smartwatch, FitBit Versa 2 and Home Spirometer in people with Chronic Obstructive Pulmonary Disease, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Hyfe Smartwatch, FitBit Versa 2 and Home Spirometer
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Wu, MD contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Maryann Calligan, MA
Robert Wu, MD
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Hyfe Smartwatch, FitBit Versa 2, Home Spirometer, Audio recording
- Keywords
- Remote Clinical Monitoring, COPD, Wearables, Digital Health, Self-management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyfe SmartwatchDevice
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 2Device
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 SpirometerDevice
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 recordingBehavioural
Patients will be asked to record several sentences which will be analyzed to detect speech patterns that may indicate changes in respiratory conditions.
| Study group | Role | What they receive |
|---|---|---|
| Full study intervention | Experimental | 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 Receives: Device: Hyfe Smartwatch; Device: FitBit Versa 2; Device: Home Spirometer; Behavioral: Audio recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 90 days
Acceptability by patients and clinicians
Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview
Measured: 90 days
Actual usage over 90 days
Actual usage of all program components determined objectively through logs
Measured: 90 days
Secondary outcomes (1)
Readmissions within 30 days
Readmissions to hospital within 30 days of discharge compared to control groups in past studies
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Salvation Army Toronto Grace Health Centre, University of Toronto
- Responsible party
- Principal investigator, Robert Wu, University Health Network, Toronto
- Investigators
- Robert Wu, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253013
- Sponsor's protocol ID
- 23-5062
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The UHN research team (principal investigator, research coordinator and other delegated research staff) will have access to all source data and documents. A dataset will be created with de-identified data from RCM. We will seek broad consent from participants for the future unspecified use of this data. This is in line with TCPS2 and CIHR funding guidelines to ensure data generated from this study is available to other researchers both in Canada and outside to inform improve patient, population and systems outcomes. The TGHC and UHN clinical teams will have access to PHI to conduct VPR and Integrated Care, and for clinical escalation when required from RCM. The UHN, TGHC, and U of T research teams will have access to anonymized data for analysis purposes.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06253013
- Acronym / sponsor ID
- 23-5062
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Remote Clinical Monitoring, COPD, Wearables, Digital Health, Self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Salvation Army Toronto Grace Health Centre, University of Toronto
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full study intervention | Experimental | Device: Hyfe Smartwatch, Device: FitBit Versa 2, Device: Home Spirometer, Behavioral: Audio recordingIn 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyfe SmartwatchPassive 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. | Device | Full study intervention |
| FitBit Versa 2Commercial 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. | Device | Full study intervention |
| Home SpirometerPatients 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. | Device | Full study intervention |
| Audio recordingPatients will be asked to record several sentences which will be analyzed to detect speech patterns that may indicate changes in respiratory conditions. | Behavioural | Full study intervention |
Primary outcome
Feasibility of the program and research study
Time frame: 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%).
Acceptability by patients and clinicians
Time frame: 90 days
Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview
Actual usage over 90 days
Time frame: 90 days
Actual usage of all program components determined objectively through logs
1 secondary outcome
Readmissions within 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. The UHN research team (principal investigator, research coordinator and other delegated research staff) will have access to all source data and documents. A dataset will be created with de-identified data from RCM. We will seek broad consent from participants for the future unspecified use of this data. This is in line with TCPS2 and CIHR funding guidelines to ensure data generated from this study is available to other researchers both in Canada and outside to inform improve patient, population and systems outcomes. The TGHC and UHN clinical teams will have access to PHI to conduct VPR and Integrated Care, and for clinical escalation when required from RCM. The UHN, TGHC, and U of T research teams will have access to anonymized data for analysis purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Wu, MD contact
Robert Wu, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyfe Smartwatch, FitBit Versa 2 and Home Spirometer in people with Chronic Obstructive Pulmonary Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Tu, MA (647-381-7024, alice.tu2@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the program and research study (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.