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临床试验/NCT04423289
NCT04423289已完成不适用

COVID Follow-App: Telematic Monitoring Through a Mobile Application of Patients With COVID-19: A Randomized Clinical Trial

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Re-consultation

研究概览

简要总结

Open-label randomized clinical trial, one center, to compare the need for face-to-face re-consultation after discharge for COVID-19 between a telematic monitoring through a mobile app and the regular primary care setting.

详细描述

A randomized, open-label clinical trial, at one center, a 1100-bed academic hospital, Vall d'Hebron Hospital Universitari, in Barcelona, Spain. Patients who met the enrolment criteria were randomly assigned, in a 1:1 ratio, to be followed by the Farmalarm app or the primary care setting.

Farmalarm is an app for smartphones designed to increase stroke awareness and treatment compliance through visual and audible alerts. The application's software offers versatility to modify the parameters to be monitored and the information to be sent, which were adapted to our purpose.

Intervention was started after the patient was discharged and underwent randomization. At this moment, patients assigned to the study group were given a personal access code ensuring data privacy, and they were lent an intelligent pulse oximeter (SMART PULSE OXIMETER OL-750, LifeVit, Guangdong Biolight Meditech CO., LTD, China). In a 15 minutes interview they were trained in the use of the app, the use of the pulse oximeter and the measurement of some vital signs.

On that same day, the healthcare professional uploaded and scheduled on the web-based platform a personalized program for the following 2 weeks.

To maintain close control of respiratory evolution, patients registered at least 2 times a day their heart rate, respiratory rate, temperature and peripheral capillary oxygen saturation. The intelligent pulse oximeter allowed data to be downloaded directly to the WP every time the patient used it. They also had to answer a symptom survey every day for the same period. The WP allows scheduling alarms and so, in case one of the vital signs or survey responses were altered, the healthcare in charge automatically received a notification, being able to contact immediately the patient. A private chat between the patient and the healthcare responsible for WP was attended every day from 8 AM to 5 PM to answer any doubt.

研究设计

研究类型
Interventional
分配方式
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

入选标准

  • an age of 18 years or older,
  • availability of a mobile device such a phone or a tablet with connectivity to the internet, and
  • discharged from hospital after admission for COVID-19 diagnosed by RT-PCR.

排除标准

  • health personnel (medical or nursing staff) or
  • discharged to care centers or medicalized hotels enabled to complete the period of isolation.

结局指标

主要结局

Re-consultation

时间窗: 2 weeks

Number of patients needing face-to-face re-consultations

次要结局

  • Telephone calls(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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