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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility of the program and research study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Hyfe Smartwatch (Device)
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
干预措施: FitBit Versa 2 (Device)
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
干预措施: Home Spirometer (Device)
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
干预措施: Audio recording (Behavioral)
结局指标
主要结局
Feasibility of the program and research study
时间窗: 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
时间窗: 90 days
Actual usage of all program components determined objectively through logs
Acceptability by patients and clinicians
时间窗: 90 days
Acceptability of the program as determined by patient questionnaire as well as patient and health care provider interview
次要结局
- Readmissions within 30 days(30 days)
研究者
Robert Wu
Doctor
University Health Network, Toronto