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临床试验/NCT05715593
NCT05715593已完成不适用

The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial

University of Monastir2 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2021年2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
402
试验地点
2
主要终点
The rate of anxiety reduction

研究概览

简要总结

we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.

详细描述

This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization

排除标准

  • Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.

结局指标

主要结局

The rate of anxiety reduction

时间窗: One week (7 days) after the COVID 19 diagnosis

The rate of anxiety reduction in each group at Day 7 based on a HAD-A score ≥ 8

次要结局

未报告次要终点

研究者

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

Imen Zemni

Medical doctor

University of Monastir

研究点 (2)

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