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临床试验/NCT05758649
NCT05758649已完成不适用

Cardiovascular and Psychological Consequences of COVID-19

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2020年10月1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
104
试验地点
1
主要终点
prevalence of patients with cardiovascular or psychological sequelae

研究概览

简要总结

The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.

详细描述

A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.

Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.

The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.

A second follow-up visit will be performed at 12 months in the form of structured interview,

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease

排除标准

  • Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
  • Non-Italian education, illiteracy, or return to illiteracy.
  • Severe visual-perceptual deficits.
  • Low motivation/interest or refusal to undergo the assessment.

结局指标

主要结局

prevalence of patients with cardiovascular or psychological sequelae

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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