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临床试验/NCT02435641
NCT02435641已完成不适用

A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

The current study has the following objectives:

  1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression, PTSD, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment.
  2. To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3.

The investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic 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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Measures symptoms of anxiety and depression.

World Health Organization QOL Questionnaire (WHOQOL-BREF)

时间窗: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.

Posttraumatic Stress (PCL-S)

时间窗: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Measures symptoms of posttraumatic stress disorder

Satisfaction with Life Questionnaire (SWL)

时间窗: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Measures global cognitive judgements of satisfaction with one's life

次要结局

  • Caregiver Self-Efficacy Scale(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Cognitive and Affective Mindfulness Scale (CAMS)(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Qualitative Adherence Measure(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • General Self-Efficacy Scale(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Distress Thermometer Scale(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Visual Analog Stress Scale(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Healthcare satisfaction (CSQ-8)(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Patient-caregiver interaction (Intimate Bond Measure)(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Measure of Current Status (MOCS-A)(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))
  • Caregiving Preparedness (Preparedness for Caregiving Scale)(Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26))

研究者

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

Ana-Maria Vranceanu, PhD

Clinical Psychologist

Massachusetts General Hospital

研究点 (1)

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