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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Hyfe Smartwatch; Device: FitBit Versa 2; Device: Home Spirometer; Behavioral: Audio recording

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maryann Calligan, MA; Phone Number: 647-381-7024; Email: maryann.calligan@uhn.ca
• Study Contact Backup: Name: Robert Wu, MD; Email: robert.wu@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2C4
      • Recruiting
      • University Health Network
      • Contact: Maryann Calligan, MA
      • Principal Investigator: Robert Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.; 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.; 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the program and research study	Feasibility of the study and the program of care as determined by study participation and completion	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmissions within 30 days	Readmissions to hospital within 30 days of discharge compared to control groups in past studies	30 days

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: University of Toronto; The Salvation Army Toronto Grace Health Centre
• Investigators: Principal Investigator: Robert Wu, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Digital Health; Self-management; Wearables; Remote Clinical Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 23-5062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will become available after study completion and for up to 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No