Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Self-management and Activation
研究概览
简要总结
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.
详细描述
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
COPD is a pervasive disease that is estimated to affect 2.6 million Canadians (17%) aged 35 to 79 costing the healthcare system in Canada $1.5 billion annually. Ontarians living with COPD are frequent users of the health care system and account for 24% of hospital admissions and 24% of emergency department (ED) visits. COPD is responsible for the highest percentage (18.8%) of 30-day re-admissions to ED in the province.
A recent Cochrane review and meta-analysis concluded that remote monitoring has shown promise in reducing acute care utilization and reducing the number of exacerbations in COPD patients. While many studies have examined the effects of remote-monitoring, few studies have looked at how self-monitoring without clinical oversight affects patients' self-management skills and quality of life. Our goal is to compare a group of patients that are in both self- and remote-monitoring to a group of patients that are only in a self-monitoring program and compare each relative to a standard care group.
The technology used in this study is the Cloud Dx Connect Health Kit which will be used as a tool for self-monitoring and asynchronous remote-monitoring. It consists of a custom Tablet computer, Pulsewave® wrist cuff monitor, Oximeter, Scale and Therometer. Participants will use the kit to record daily their physiological and symptom readings.
This study will take place at Markham-Stoufville hospital with most patients being recruited from the Outpatient COPD Clinic (Respiratory Health-COPD Clinic) and will include patients who have a clinical diagnosis of COPD that has been diagnosed by their respirologist as per clinical guidelines. Recruitment will be ongoing until 123 patients have been recruited for the intervention phase. Once enrolled, participants will be randomized into one of three arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
排除标准
- •Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
- •Lack of WiFi at home
- •Inability to speak English
- •Inability to use this technology due to physical or cognitive impairment
研究组 & 干预措施
Remote-Monitoring Program
Cloud Dx kit with remote-monitoring
干预措施: Cloud Dx Kit with remote-monitoring (Device)
Self-Monitoring Program
Cloud Dx kit with self-monitoring
干预措施: Cloud Dx Kit with self-monitoring (Device)
Standard of Care
Participants will not be provided with the Cloud DX kit or an action plan
结局指标
主要结局
Self-management and Activation
时间窗: 6 Months
Measured with the Partners in Health Scale (PIHS)
次要结局
- Patient Knowledge of COPD(6 Months)
- COPD Assessment(6 Months)
- Total length of stay for all admissions (in days)(6 Months)
- Breathlessness(6 Months)
- Total number of ED presentations, admissions to a hospital, exacerbations, visits to family doctor, number of nurse contacts, self-reported use of medication, self-reported smoking cessation(6 Months)
- Quality of Life and Respiratory symptoms(6 Months)
- Total number of contacts/calls to the outpatient clinic and deaths(6 Months)