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临床试验/NCT04515199
NCT04515199Unknown不适用

Effectiveness of Telemedicine Use in Home Management of Adult Egyptian Mild COVID-19 Cases

Cairo University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Percent of adherence to isolation measures

研究概览

简要总结

Keeping in mind the rising number of cases in Egypt and the strain they put on hospital infrastructure, the idea of home isolation and follow up for COVID 19 positive cases has been adopted in many countries and was approved by World Health Organization (WHO) and Egyptian Ministry of health (MOH).

Telehealth can help to mitigate this risk by minimizing the amount of face-to-face interactions. The WHO mentioned telemedicine among essential services in "strengthening the Health Systems Response to COVID-19" policy. The aim in this study is to study the effectiveness of telemedicine in managing mild COVID cases regarding isolation measures, symptoms, medications adherence, and reporting of red flags and side effects.

详细描述

Objectives:

  • To assess the effectiveness of follow up of mild COVID-19 cases in home isolation
  • To assess the applicability of telemedicine tools in the follow up of those patients and early identification of warning symptoms needing more intensive management measures.
  • To assess the clinical characteristics for mild COVID-19 cases and post covid sequelae and the course of symptoms
  • To assess the persistence of symptoms during follow up.
  • To assess the quality of life during home management period.
  • To assess cost-effectivenes of home isolation vs hospital admission in mild COVID-19 cases.

Study population & Sample size :

The study includes 400 Adult (18-65 years) Egyptian patients with mild COVID 19 diagnosed by PCR consented (oral consent) to home isolation to follow them.

Study Design:

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No co-morbidities that necessitates hospital admission due to high risk for progression of the disease: Pregnancy, uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency.
  • No fever (oral, below or equal 37.50 C )
  • No shortness of breath (Respiratory rate 12-20/min)
  • Oxygen saturation >= 96 %
  • CT chest: Normal
  • Labs: D-dimer<1000ng/ml, CPK< twice upper limit of normal, CRP<100, LDH<245, Ferritin<500, absolute lymphocytic count >0.8

排除标准

  • Moderate and severe cases not fulfilling the definition of mild cases.
  • Children and young < 18 years.
  • Age >65 years.
  • Presence of any of the previously mentioned comorbidities.

结局指标

主要结局

Percent of adherence to isolation measures

时间窗: 3-6 months

A checklist to check the percent of the patients who followed the advices for home isolation and will be validated

The incidence of symptoms and their duration

时间窗: 3-6 months

days

次要结局

  • Change in Short Form 35 (SF-36) Questionnaire(3-6 months)
  • Cost- effectiveness of Home Isolation vs hospital admission in mild COVID-19 cases(3-6 months)
  • Identifying the duration of post-COVID-19 symptoms(3-6 months)
  • long-term respiratory complications(3-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Tharwat Hegazy

Lecturer of Internal Medicine, Rheumatology and Clinical Immunology

Cairo University

研究点 (1)

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