COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
研究概览
简要总结
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.
详细描述
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better.
Research questions:
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to speak English
- •Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines
- •Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months
- •Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted
- •Patient resides at home (not long term care residence or another hospital)
排除标准
- •Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
- •Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease
- •Any medical conditions that would impair their ability to participate in the study
结局指标
主要结局
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
时间窗: 6 months
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD? We will use the Mastery sub-section of the Chronic Respiratory Disease Questionnaire to measure our research question. Mastery is measured with a 7-point likert scale where higher scores indicate better health-related mastery.
次要结局
- Change in self-efficacy as measured by the COPD Self-Efficacy Scale(6 months)
- Change in Health related quality of life as measured by the St. George's respiratory questionnaire(6 months)
- Change in symptom scale as measured by the MRC dyspnea scale(6 months)
- Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.(6 months)
研究者
Robert Wu
General Internal Medicine Site Director
University Health Network, Toronto