跳至主要内容
临床试验/NCT03915977
NCT03915977已完成不适用

Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial

Holbaek Sygehus1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2012年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
386
试验地点
1
主要终点
Post traumatic stress disorder (PTSD)

研究概览

简要总结

This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

详细描述

The present study is a secondary analysis of the RAPIT-trial study treating data from patients on Post-traumatic stress disorder (PTDS) (Jensen et al., 2016).

Design Observational study based on data from the RAPIT trial that is a non-blinded, multicentre, parallel-group RCT conducted between December 2012-2015, at 10 intensive care units (ICUs) in four out of five regions in Denmark.

Participants Patients were consecutively recruited during the first 18 months of the study. We included Danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. We excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. A total of 386 adult patients were randomized to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC).

Outcomes In this study, we will describe variations in patients, who experience symptoms of PTSD at ICU-discharge, 3 and 12 months after intensive care based on the data collection in the RAPIT-trial (Jensen et al., 2016). We will report trial participants' symptoms of PTSD at baseline, three months and twelve months after Intensive care using the Harvard Trauma Questionnaire (HTQ) supplemented with descriptions of patients' experiences of PTSD. Symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. We will use descriptive statistical methods to analyze data.

Symptoms of PTSD by HTQ-IV consisted of 17 items covering three core symptoms corresponding to DSM-IV criteria for PTSD: re-experience (5 items), avoidance (7 items), and arousal (5 items). This was supplemented by four additional items: one functional and three related to stress. We used a total score, and a cut-off of ≥40 is categorized as "positive PTSD". Symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
  • Undiagnosed dementia

排除标准

  • Delirium at randomization (positive CAM-ICU score)
  • Participations in scientific projects which include patient interviews
  • Not speaking or understanding danish.

结局指标

主要结局

Post traumatic stress disorder (PTSD)

时间窗: 12 months

Harvard Trauma Questionnaire, Range 18-72

次要结局

  • Depression(Over time at 3 months and 12 months)
  • PTSD(Over time at baseline, 3 and 12 months)
  • Anxiety(Over time at 3 and 12 months)

研究者

发起方
Holbaek Sygehus
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Patterns of PTSD in Adult Patients After Intensive... | 临床试验