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Clinical Trials/NCT06253013
NCT06253013
Recruiting
Not Applicable

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

University Health Network, Toronto1 site in 1 country100 target enrollmentSeptember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University Health Network, Toronto
Enrollment
100
Locations
1
Primary Endpoint
Feasibility of the program and research study
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
June 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Wu

Doctor

University Health Network, Toronto

Eligibility Criteria

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

Outcomes

Primary Outcomes

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%).

Actual usage over 90 days

Time Frame: 90 days

Actual usage of all program components determined objectively through logs

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

Secondary Outcomes

  • Readmissions within 30 days(30 days)

Study Sites (1)

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