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临床试验/NCT02275234
NCT02275234已完成不适用

A Feasibility Study of Implementing a Simple Psychological Intervention in Survivors of Cardiac Arrest and Their Family Members/Friend to Assess the Impact on Their Quality of Life and Cognitive Function

Mid and South Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年9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
75
试验地点
1
主要终点
Change in cognitive function as measured by responses on Montreal Cognitive function tool

研究概览

简要总结

The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.

详细描述

At the Essex Cardiothoracic Centre (CTC) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate.

The purpose of this study is to investigate simple psychological interventions can be implemented here at the Essex CTC with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.

The investigators propose to recruit 2 groups of patients. The first group will be chosen from patients who have already survived a cardiac arrest > 3 months prior to the start of the study. Participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the Essex CTC with members of the research team. The investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. A referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression.

The second group will be recruited from patients who survive cardiac arrest from the start of study date. Participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. Baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. At around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. At the end of the study, the data between the 2 groups will be analysed.

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

  • Anyone surviving cardiac arrest
  • Age greater than or equal to 18 yrs
  • Cerebral Performance Category (CPC) 1-2 at the time of discharge from hospital
  • English speaking
  • Able to give informed consent

排除标准

  • Age less than 18yrs
  • CPC 3-5 at the time of discharge from hospital
  • Non-English speaking
  • Unable to give informed consent

结局指标

主要结局

Change in cognitive function as measured by responses on Montreal Cognitive function tool

时间窗: 6 months

Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends

Change in Quality of Life as measured by responses on SF36

时间窗: 6 months

Change in Quality of Life before and after psychological intervention in patients surviving cardiac arrest and their family/friends

Change in cognitive function as measured by responses on Cogfail questionnaire

时间窗: 6 months

Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends

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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