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 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2023
CompletedFirst Submitted
Initial submission to the registry
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJanuary 27, 2025
January 1, 2025
1.7 years
January 31, 2024
January 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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%).
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
90 days
Actual usage over 90 days
Actual usage of all program components determined objectively through logs
90 days
Secondary Outcomes (1)
Readmissions within 30 days
30 days
Study Arms (1)
Full study intervention
EXPERIMENTALIn 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
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.
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.
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.
Patients will be asked to record several sentences which will be analyzed to detect speech patterns that may indicate changes in respiratory conditions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- The Salvation Army Toronto Grace Health Centrecollaborator
- University of Torontocollaborator
Study Sites (1)
University Health Network
Toronto, Ontario, M5G2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wu, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
January 31, 2024
First Posted
February 12, 2024
Study Start
September 15, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
January 27, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available after study completion and for up to 5 years.
- Access Criteria
- Data will be stored and analyzed on the secure UHN server. De-identified data will be analyzed by trained study personnel at the University of Toronto.
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.