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CHARM-COPD Program of Care

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ClinicalTrials.gov Identifier: NCT06253013
Recruitment Status : Recruiting
First Posted : February 12, 2024
Last Update Posted : May 16, 2024
Sponsor:
Collaborators:
The Salvation Army Toronto Grace Health Centre
University of Toronto
Information provided by (Responsible Party):
Robert Wu, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE January 31, 2024
First Posted Date  ICMJE February 12, 2024
Last Update Posted Date May 16, 2024
Actual Study Start Date  ICMJE September 15, 2023
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2024)
  • 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%).
  • 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
  • Actual usage over 90 days [ Time Frame: 90 days ]
    Actual usage of all program components determined objectively through logs
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2024)
  • 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
  • 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
  • Actual usage over 90 days [ Time Frame: 90 days ]
    Actual usage of all program components determined objectively through logs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2024)		 Readmissions within 30 days [ Time Frame: 30 days ]
Readmissions to hospital within 30 days of discharge compared to control groups in past studies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHARM-COPD Program of Care
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
Interventions:
  • Device: Hyfe Smartwatch
  • Device: FitBit Versa 2
  • Device: Home Spirometer
  • Behavioral: Audio recording
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2024)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maryann Calligan, MA 647-381-7024 maryann.calligan@uhn.ca
Contact: Robert Wu, MD robert.wu@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06253013
Other Study ID Numbers  ICMJE 23-5062
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
Current Responsible Party Robert Wu, University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • The Salvation Army Toronto Grace Health Centre
  • University of Toronto
Investigators  ICMJE
Principal Investigator: Robert Wu, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP