CHARM-COPD Program of Care
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Hyfe SmartwatchDevice: FitBit Versa 2Device: Home SpirometerBehavioral: Audio recording
- Registration Number
- NCT06253013
- Lead Sponsor
- University Health Network, Toronto
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Full study intervention Hyfe Smartwatch 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 Full study intervention FitBit Versa 2 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 Full study intervention Home Spirometer 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 Full study intervention Audio recording 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
- Primary Outcome Measures
Name Time Method Feasibility of the program and research study 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%).
Actual usage over 90 days 90 days Actual usage of all program components determined objectively through logs
Acceptability by patients and clinicians 90 days Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview
- Secondary Outcome Measures
Name Time Method Readmissions within 30 days 30 days Readmissions to hospital within 30 days of discharge compared to control groups in past studies
Trial Locations
- Locations (1)
University Health Network
🇨🇦Toronto, Ontario, Canada