Care After Resuscitation

Cardiac Arrest Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275234
• Other study ID #: B709
• Status: Completed
• Start date: September 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2021
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Other:
• Psychological intervention
Psychological support via clinic visit, helpline and telephone calls

Locations

Country	Name	City	State
United Kingdom	The Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life as measured by responses on SF36	Change in Quality of Life before and after psychological intervention in patients surviving cardiac arrest and their family/friends	6 months
Primary	Change in cognitive function as measured by responses on Montreal Cognitive function tool	Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends	6 months
Primary	Change in cognitive function as measured by responses on Cogfail questionnaire	Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends	6 months