Testing Hyfe Smartwatch with FitBit Versa 2 for chronic obstructive pulmonary disease
Official title: 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
- 1 group
- One site, in Toronto
- Recruiting
Interventions (4)
- Medical 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.
- Medical device
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.
- Medical device
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.
- Behavioural therapy
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario
Eligibility Criteria
See who this study is looking for4 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and to follow study processes
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group, which receives one or more of: Hyfe Smartwatch, FitBit Versa 2, Home Spirometer and Audio recording.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: 90 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of the program and research study — measured over 90 days.
Acceptability by patients and clinicians — measured over 90 days.
Actual usage over 90 days — measured over 90 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06253013 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 90 days.
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.