CHARM-COPD Program of Care

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility of the program and research study [Срок оценки: 90 days]
• Acceptability by patients and clinicians [Срок оценки: 90 days]
• Actual usage over 90 days [Срок оценки: 90 days]

Вторичные конечные точки (1)

• Readmissions within 30 days [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• University Health Network — Toronto

Идентификаторы

NCT: NCT06253013 · 23-5062

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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