NCT04399109Unknown不适用
ReCOVER (Remote COVID-19 Evaluation and Response): a Prospective Non-randomised Controlled Trial to Evaluate the Effect of a Novel Smartphone Application-centric Model of Care for the Remote Monitoring of COVID-19 Patients in the Community.
Dr Sze-Yuan Ooi6 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case
研究概览
简要总结
This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age greater or equal to 18 years
- •Able to provide informed consent
- •Proven diagnosis of COVID-19 based on positive virology testing
- •Patients who are being managed at home OR those who are being discharged from hospital for ongoing home-based care in isolation.
- •Access to a smartphone or device that is compatible with the TCC-COVID app
- •Any iPhone or iPad running iOS 9 or above (essentially any iPhone 5 or above)
- •Any Android phone that is operating Android 7.0 or above
- •Speaks adequate English
排除标准
- •Patient meets clinical criteria for hospital-based care.
- •Inability to use the TCC-COVID app and pulse oximeter due to reasons including but not limited to:
- •Cognitive impairment
- •Impaired dexterity
- •Visual impairment
- •Language barrier
- •Patient residing outside the SESLHD catchment area during their period of isolation
结局指标
主要结局
Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case
时间窗: 12 months
Definition based on potentially avoidable general practitioner-type presentations as specified in the National Healthcare
All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case
时间窗: 30 days
次要结局
- Rate of hospital admission per diagnosed COVID case(12 months)
- Rate of admission to Intensive Care Unit (ICU) for admitted patients per diagnosed COVID case(12 months)
- Rate of MBS claims for un-referred visits to general practitioners and analogous COVID-19 MBS telehealth items per diagnosed COVID case(12 months)
- Time from presentation to admission to ICU for patients admitted to ICU per diagnosed COVID case(12 months)
- Rate of hospital admission with COVID-19 diagnosis per 100,000 population, during trial period(12 months)
- Average length of stay (LOS) for admitted patients per diagnosed COVID case(12 months)
- Rate of intubation in admitted patients per diagnosed COVID case(12 months)
- All-cause mortality at 90 days per diagnosed COVID case(90 days)
- Rate of avoidable Emergency Department presentations with COVID-19 diagnosis per 100,000 population, during trial period(12 months)
- Rate of ICU bed days with COVID-19 diagnosis per 100,000 population, during trial period(12 months)
- Rate of readmission within 30 days of discharge in admitted patients per diagnosed COVID case(30 days)
- Qualitative assessment of KIOLA physician portal usability via a subjective feedback questionnaire(12 months)
- Rate of admission to ICU with COVID-19 diagnosis per 100,000 population during trial period(12 months)
- Rate of mortality with COVID-19 cause of death per 100,000 population, during trial period(12 months)
- Cost-effectiveness of TCC-COVID by measuring the incremental cost per death averted, per ICU admission averted and per length of stay in ICU(12 months)
- Qualitative assessment of TCC-COVID app usability via a subjective feedback questionnaire provided to all patients enrolled in the study.(12 months)
- Rate of hospital bed days with COVID-19 diagnosis per 100,000 population, during trial period(12 months)
研究者
Dr Sze-Yuan Ooi
Director, Coronary Care Unit and Senior Staff Cardiologist
Prince of Wales Hospital, Sydney
研究点 (6)
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