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Recruiting

NCT Number: NCT06253013

CHARM-COPD Program of Care

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location status: Recruiting

Location contact

Maryann Calligan, MA

CONTACT

Robert Wu, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyfe Smartwatch

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

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

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

Behavioral

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

Primary outcomes

  1. 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%).

  2. 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

  3. Actual usage over 90 days

    Time frame: 90 days

    Actual usage of all program components determined objectively through logs

Secondary outcomes

  1. Readmissions within 30 days

    Time frame: 30 days

    Readmissions to hospital within 30 days of discharge compared to control groups in past studies

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Tu, MA

CONTACT

[email protected]

647-381-7024

Robert Wu, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Salvation Army Toronto Grace Health Centre
  • University of Toronto

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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