Impact of an Early and Comprehensive Communication Strategy in the Prevention of Depressive Symptoms in Patients with Severe Covid-19, Their Families and Health Personnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Rate of depressive symptoms
研究概览
简要总结
The purpose of this study is to compare the effect of an early and integral communication strategy (EICS) versus standard care, on the rate of depressive symptoms at 3 months after discharge from the ICU, in patients with severe Covid-19, their family members and health personnel.
Evaluating the rate of depressive symptoms at 3 months after discharge from the ICU, with a) Hospital Anxiety and Depression, b) Posttraumatic Stress Disorder Checklist (S)
详细描述
We designed a pre-post intervention study, the groups were non-randomly allocated.
The study is implementation in 10 Chilean hospitals, admitting 350 patients.
Pre-intervention: The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.
Post-intervention: EICS to facilitate communication between the family, patient and health team, through written material, via the web (tablet and webmaster) and by telephone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adults> 18 years old
- •Admitted to the ICU
- •Requiring Mechanical Ventilation> 12 hrs due to COVID-19
排除标准
- •Patients with therapeutic proportionality is defined early
- •Patients with communication limitations (they do not speak Spanish) are excluded.
研究组 & 干预措施
Traditional communication management (Pre-intervention)
Traditional communication practices are maintained, which consists of reporting the patient's medical conditions or specific requirements of the case, between the health team and the family.
According to the social and administrative conditions of each centers, medical telephone information is provided on the conditions of the patients.
Early and integral communication strategy (EICS) (Post-intervention)
EICS that includes a bundle of various strategies that allow to favor communication and contact between family members, patients and health team.
That considers the delivery of: (1) Receive timely and understandable information; (2) Receive visits, companionship, and spiritual assistance
干预措施: Intervention. Early and integral communication strategy (EICS) (Behavioral)
结局指标
主要结局
Rate of depressive symptoms
时间窗: Third month post-discharge from ICU
The rate of depressive symptoms after discharge from the ICU will be evaluated in patients with severe Covid-19, their relatives and health personnel with the instrument HADS (Hospital Anxiety and Depression Scale)
次要结局
- Risk factors of depressive symptoms(Third month post-discharge from ICU)
- Cognition status post-ICU(Twelfth month post-discharge from ICU)
- ICU memories post ICU(Twelfth month post-discharge from ICU)
- Functional independence post-ICU(Twelfth month post-discharge from ICU)
- Post traumatic stress post-ICU(Twelfth month post-discharge from ICU)
- Functionality Status post-ICU(Twelfth month post-discharge from ICU)
- Anxiety post ICU(Twelfth month post-discharge from ICU)
- Quality of life post ICU(Twelfth month post-discharge from ICU)
- Rate of depressive symptoms(Twelfth month post-discharge from ICU)
- Cognition status post-ICU(Third month post-discharge from ICU)
- Functional independence post-ICU(Third month post-discharge from ICU)
- Functionality Status post-ICU(Third month post-discharge from ICU)
- Post traumatic stress post-ICU(Third month post-discharge from ICU)
- Quality of life post ICU(Third month post-discharge from ICU)
- ICU memories post ICU(Third month post-discharge from ICU)
- Anxiety post ICU(Third month post-discharge from ICU)