Health TrialsbyHealthPanel

CHARM-COPD Program of Care

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Full study interventionExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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%).

Time frame
90 days
2

Acceptability by patients and clinicians

Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview

Time frame
90 days
3

Actual usage over 90 days

Actual usage of all program components determined objectively through logs

Time frame
90 days

Secondary outcomes

1

Readmissions within 30 days

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

The Salvation Army Toronto Grace Health Centre

Collaborator

University of Toronto

Collaborator

Source ClinicalTrials.gov
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