Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the usability of the Opal app for COVID-19
研究概览
简要总结
In collaboration with involved healthcare professionals and a patient advisory committee, this study tests the feasibility of using the Opal smartphone app to daily capture self-reported physical and psychological symptoms and vital signs among 50 people who are self-isolating at home with COVID-19. A healthcare team at Montreal's MUHC will remotely monitor their condition and offer advice and teleconsultations, as needed.
详细描述
In the context of the current pandemic, guidelines were issued by public health authorities to follow the progression of COVID-19 in the community, identify and treat affected people, and limit transmissions. About 90% of people with COVID-19 only exhibit mild symptoms and recover. However, a small percentage of people experience serious symptoms and require hospitalization for severe shortness of breath or low oxygen levels. The current public health protocol is to identify people with COVID-19 and isolate them from others at home to prevent the virus from spreading. Currently, there is no consensus on how to effectively follow-up and treat individuals with COVID-19 who are self-isolating at home. Research is urgently needed. This pilot study will assess the feasibility of one strategy for home-based COVID-19 follow-up . The Opal app for COVID is a mobile application that will allow the completion of a daily symptom and vital sign follow-up questionnaire that will be monitored by a healthcare team. Educational material will also be provided through the app. The study will especially assess the acceptability and usability of the smartphone app.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Fluent in English and/or French
- •Confirmed positive for PCR+ SARS-CoV-2
- •Willing and able to understand the requirements of study participation and provide oral informed consent
- •Access to a smartphone, tablet or computer at home
- •Access to an internet connection at home or data plan on their smartphone
- •Comfortable with the idea of using a new smartphone application to complete daily questionnaires, access educational material, and communicate with the healthcare team, or having someone to assist them with technology
- •Prescribed self-isolation at home
- •Proof of identity (passport, RAMQ, driver's license)
排除标准
- •Have received a negative laboratory test result for the infection with COVID-19
- •Confirmed negative for PCR+ SARS-CoV-2 and hospitalized
- •Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a smartphone application
- •Enrollment in any study involving an investigational drug for COVID-19 disease during the study period
结局指标
主要结局
Change in the usability of the Opal app for COVID-19
时间窗: from day 1 to day 14
the Health Information Technology Usability Evaluation Scale
Change in the acceptability of the Opal app for COVID-19
时间窗: from day 1 to day 14
the Acceptability of Intervention Measure
次要结局
- Change in symptoms(from day 1 to day 14)
- Change in vital signs blood pressure(from day 1 to day 14)
- Contact with the healthcare team(from day 1 to day 14)
- Change in vital signs respiration rate(from day 1 to day 14)
- Change in vital signs oxygen saturation(from day 1 to day 14)
- Change in vital signs heart rate(from day 1 to day 14)
- Patient satisfaction with scheduled teleconsultations(from day 1 to day 14)
- Change in vital signs temperature(from day 1 to day 14)
研究者
Dr. Bertrand Lebouche
Bertrand Lebouché MD, PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre