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Clinical Trials/NCT02275234
NCT02275234
Completed
Not Applicable

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 site in 1 country75 target enrollmentSeptember 2014
ConditionsCardiac Arrest

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Mid and South Essex NHS Foundation Trust
Enrollment
75
Locations
1
Primary Endpoint
Change in cognitive function as measured by responses on Montreal Cognitive function tool
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 31, 2017
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 6 months

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

Study Sites (1)

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