CHARM-COPD Program of Care

NCT ID: NCT06253013

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hyfe Smartwatch

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Salvation Army Toronto Grace Health Centre

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Robert Wu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Wu, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Alice Tu, MA

Role: CONTACT

647-381-7024

Robert Wu, MD

Role: CONTACT

Facility Contacts

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Maryann Calligan, MA

Role: primary

Other Identifiers

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23-5062

Identifier Type: -

Identifier Source: org_study_id

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